Hanfodion:
Sut i Mewnforio Eich Data i Mewn i Freeform
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OverviewImporting your CT data correctly into Geomagics Freeform is an important step to avoid designs that don't fit the anatomy. ​ It's important to understand the different options and how they will affect the patient's anatomy to produce a safe and effective design process and end result. ​ In this video, we take a closer look at these import options and they change the patients anatomy, including: Measurement units Clay, buck and mesh models and their properties Model resolution Voxels, voids and filling holes X,Y,Z global model position
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Further ReadingRelevent research paper links / citations
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AttributionsCT scanner videography by RhPAP is licensed under CC BY 3.0
__Lecture 1: Clause 7 Product Realisation
Caption Examples - English
When our unique appearances change through disease or injury, we can design reconstructive implants customised for each patient. We call this 'custom medical device design' | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Custom medical devices are regulatory riddled & expensive, but the reduced likelihood of revision surgeries & reduced duration of in-patient admissions, the overall treatment cost can decrease | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Using CT scan data for 3D computer-aided planning, design, and direct manufacture of the final custom devices is state-of-the-art | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Pan fydd ein hedrychiad unigryw’n newid oherwydd afiechyd neu anaf, gallwn ddylunio mewnblaniadau adluniol wedi'u teilwra i bob claf. 'Dylunio dyfeisiau meddygol wedi’u teilwra' rydyn ni'n galw hyn | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae maes dyfeisiau meddygol wedi’u teilwra’n llawn rheoliadau ac maen nhw’n ddrud, ond gan fod tebygolrwydd is o lawdriniaeth ddiwygio a bod cleifion mewnol yn cael eu derbyn am lai o amser, gall cost gyffredinol y driniaeth leihau | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae defnyddio data sganiau CT ar gyfer cynllunio 3D gyda chymorth cyfrifiadur, dylunio, a gweithgynhyrchu uniongyrchol y dyfeisiau terfynol wedi’u teilwra ar flaen y gad | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/704624826/2e3ee67388
Download: https://vimeo.com/704639671/6805642d05
Download: https://vimeo.com/704639964/a04b5b0b7f
Vertical orientation
Download: https://vimeo.com/704619482/e9501971b3
Download: https://vimeo.com/704639348/d2a2fa86c5
Download: https://vimeo.com/704639460/7753539c13
__Lecture 2: 7.2 Customer-related processes
Caption Examples
Our patient's safety relies on the quality & reliability of medical devices. The medical device design & manufacturing sector is one of the most heavily regulated around the globe | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Developing a quality management system requires a significant & sustained amount of resources. It's a vital way to ensure patient safety, reliability, & demonstrate compliance with regulations | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
ISO 13485 has 8 clauses detailing the requirements of organizations engaged in the design, manufacture and supply of medical devices | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch ein cleifion yn dibynnu ar ansawdd a dibynadwyedd dyfeisiau meddygol. Y sector dylunio a gweithgynhyrchu dyfeisiau meddygol yw un o'r rhai mwyaf rheoleiddiedig yn y byd | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae datblygu system rheoli ansawdd yn gofyn am adnoddau sylweddol a pharhaus. Mae'n ffordd hanfodol o sicrhau diogelwch cleifion, dibynadwyedd, a dangos cydymffurfiaeth â rheoliadau | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae gan ISO 13485 8 cymal yn manylu ar ofynion sefydliadau sy'n ymwneud â’r gwaith o ddylunio, cynhyrchu a chyflenwi dyfeisiau meddygol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/704585128/086dca9be8
Download: https://vimeo.com/704585224/49c9c92c61
Download: https://vimeo.com/704585370/57dbbc2705
Vertical orientation
Download: https://vimeo.com/704584987/f614bafef5
Download: https://vimeo.com/704603696/b376f65b3a
__Lecture 3: 7.3 Design and development
Caption Examples
Our bodies are made up of a delicate balance of interconnected, complex structures. We need to evidence how our medical devices can reduce the risk of harm whilst restoring form & function | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Custom Medical Devices are divided into classifications, 1, 2A, 2B and 3. So, how do we determine which classification our devices fit into? The answer is risk | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Risk is inherent with all medical devices, but by following strict regulations, we can reduce the risk as far as possible for our patients and heal instead of harm | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae ein cyrff yn cynnwys cydbwysedd bregus o strwythurau cydgysylltiedig a chymhleth. Mae angen i ni ddangos tystiolaeth o’r ffordd y gall ein dyfeisiau meddygol leihau'r risg o niwed wrth adfer ffurf a swyddogaeth | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae Dyfeisiau Meddygol Wedi’u Teilwra wedi’u rhannu i ddosbarthiadau, 1, 2A, 2B a 3. Felly, sut ydyn ni'n penderfynu pa ddosbarthiad sy’n addas i’n dyfeisiau? Yr ateb yw risg | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae risg yn gynhenid i bob dyfais feddygol, ond trwy ddilyn rheoliadau llym, gallwn leihau'r risg i’r eithaf posibl i'n cleifion, a gwella yn lle niweidio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/705077201/1655edb08d
Download: https://vimeo.com/705077295/ac88fea784
Download: https://vimeo.com/705077460/85b1cc820f
Vertical orientation
Download: https://vimeo.com/705080361/cf88191890
Download: https://vimeo.com/705080460/94ec7c4300
Download: https://vimeo.com/705080616/6c13934a67
__Lecture 4: 7.4 Purchasing
Caption Examples
It is vital that staff use the most up-to-date, authorised documentation to ensure that they are keeping patients safe & abiding by the law. Let's explore documentation structure & control | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Good document control ensures that every document is tracked as it flows through different departments, stakeholders & third parties throughout its life cycle | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
The document structure pyramid guides us through what to do, how to do it, and how to evidence the actions you've taken, forming a traceable flow of evidence | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae'n hanfodol bod staff yn defnyddio'r dogfennau awdurdodedig mwyaf diweddar i sicrhau eu bod nhw’n cadw cleifion yn ddiogel ac yn cadw at y gyfraith. Gadewch i ni archwilio strwythur a rheolaeth dogfennaeth | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae rheoli dogfennau’n dda yn sicrhau bod pob dogfen yn cael ei holrhain wrth iddi lifo trwy wahanol adrannau, rhanddeiliaid a thrydydd partïon trwy gydol ei chylch oes | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae’r pyramid strwythur dogfennau’n ein tywys trwy beth i'w wneud, sut i'w wneud, a sut i ddangos tystiolaeth o'r camau rydych chi wedi'u cymryd, gan greu llif o dystiolaeth y gellir ei olrhain | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/705091080/acf504b5e7
Download: https://vimeo.com/705091154/2e3d6d69b9
Download: https://vimeo.com/705091279/ea3a27d29b
Vertical orientation
Download: https://vimeo.com/705093910/712f6b4d68
Download: https://vimeo.com/705093998/dbce2da7dd
Download: https://vimeo.com/705094128/c366a16f86
__Lecture 5: 7.5 Production and service provision
Caption Examples
Suffering harm is an unavoidable aspect of living. Improving safety requires us to assess & manage risk. Let's review the legal framework, ISO standards & developing our risk management files | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Defining your criteria for risk acceptability will inform the design of your risk estimation tools. Data gathered during your risk management activities will also inform your technical files | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Risk management is rewarding- it builds a team with a common goal of improving patient outcomes by making your devices as safe as possible | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae dioddef niwed yn agwedd anochel ar fyw. Er mwyn gwella diogelwch, mae’n ofynnol i ni asesu a rheoli risg. Gadewch i ni adolygu'r fframwaith cyfreithiol, safonau ISO a datblygu ein ffeiliau rheoli risg | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Bydd pennu eich meini prawf ar gyfer derbynioldeb risg yn llywio dyluniad eich adnoddau amcangyfrif risg. Bydd data a gesglir yn ystod eich gweithgareddau rheoli risg hefyd yn llywio eich ffeiliau technegol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae rheoli risg yn rhoi boddhad - mae'n meithrin tîm sydd â nod cyffredin o wella canlyniadau cleifion trwy wneud eich dyfeisiau mor ddiogel â phosibl | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/732753971/372db0fdad
Download: https://vimeo.com/732754167/fe1846c84a
Download: https://vimeo.com/732754344/30d84087a3
Vertical orientation
Download: https://vimeo.com/732755285/97fc90ecd7
Download: https://vimeo.com/732755328/d01fe6e342
Download: https://vimeo.com/732755443/81ed15d1ac
__Lecture 6: 7.6 Control of monitoring and measuring equipment
Caption Examples
A leader's role is not about being in charge; it's about taking care of those in their charge. Leadership is about having both empathy and perspective and providing a clear strategy for staff | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Although top management may not deal with day-to-day design and production, they're still expected to review improvement opportunities related to evolving levels of risk | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Improvement relies upon a cycle of communication that translates top management vision into day-to-day actions; enabling staff feedback on the effectiveness of these actions is crucial | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Nid bod wrth y llyw yw rôl arweinwyr; mae'n ymwneud â gofalu am y rhai sydd yn eu gofal. Mae arweinyddiaeth yn ymwneud â chael empathi a phersbectif a rhoi strategaeth glir i staff | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er nad yw’r uwch reolwyr, o bosibl, yn ymdrin â dylunio a chynhyrchu o ddydd i ddydd, mae disgwyl iddynt o hyd i adolygu cyfleoedd gwella sy'n gysylltiedig â lefelau risg sy'n datblygu | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae gwelliant yn dibynnu ar gylchred o gyfathrebu sy'n trosi gweledigaeth uwch reolwyr yn gamau gweithredu o ddydd i ddydd; mae galluogi adborth staff ar effeithiolrwydd y camau hyn yn hanfodol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/706512100/72ef08fc41
Download: https://vimeo.com/706512283/0d99becf1e
Download: https://vimeo.com/706512512/825df4bf0e
Vertical orientation
Download: https://vimeo.com/706512776/f0adfadf99
Download: https://vimeo.com/706512992/5f370dfe47
Download: https://vimeo.com/706513156/e53a65dcae
__Lecture 7: Fundamentals_Medical Imaging
Caption Examples
The scale and complexity of a quality management system is an inherent part of consistently ensuring patient safety. A quality manual translates our complex system into a useful tool | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Let us explore some tips for writing your quality manual for ISO 13485 | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
A quality manual is an instruction manual on operating your quality management system. It requires us to consider how our documents and processes relate to one another and clauses within 13485 | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae maint a chymhlethdod system rheoli ansawdd yn rhan gynhenid ​​o sicrhau diogelwch cleifion yn gyson. Mae llawlyfr ansawdd yn trosi ein system gymhleth yn adnodd defnyddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Gadewch inni edrych ar rai awgrymiadau ar gyfer ysgrifennu eich llawlyfr ansawdd ar gyfer ISO 13485 | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Llawlyfr cyfarwyddiadau ar weithredu eich system rheoli ansawdd yw llawlyfr ansawdd. Mae’n ei gwneud yn ofynnol i ni ystyried sut mae ein dogfennau a’n prosesau’n perthyn i’w gilydd a chymalau yn 13485 | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733156333/f919e21a7c
Download: https://vimeo.com/733156437/799bb64179
Download: https://vimeo.com/733156656/ab28473beb
Vertical orientation
Download: https://vimeo.com/733157183/a26aedfb3b
Download: https://vimeo.com/733157355/5648772e3e
Download: https://vimeo.com/733157705/77a5bd93ca
__Lecture 8: Fundamentals_Software
Caption Examples
Custom medical devices attract interesting but potentially unrealistic ideas. Expanding what’s possible is part of our field, and ensure you are operating within regulatory constraints | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
'Scope' means defining the boundaries and applicability of the activities your organisation carries out against ISO 13485 | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
A well-defined scope can help structure ideas from a medical team and focus you on creating safe solutions with specific design characteristics required for individual patients | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae dyfeisiau meddygol wedi’u teilwra’n denu syniadau diddorol ond afrealistig o bosibl. Mae ehangu’r hyn sy’n bosibl yn rhan o’n maes, a sicrhau eich bod yn gweithredu’n unol â chyfyngiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae ‘cwmpas’ yn golygu pennu ffiniau a chymhwysedd y gweithgareddau a wneir gan eich sefydliad yn erbyn ISO 13485 | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Gall cwmpas pendant helpu i strwythuro syniadau tîm meddygol a gwneud i chi ganolbwyntio ar greu atebion diogel â nodweddion dylunio penodol sy'n ofynnol ar gyfer cleifion unigol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/706535506/d508b19df0
Download: https://vimeo.com/706535594/9fff701f77
Download: https://vimeo.com/706535735/4be3fc1d44
Vertical orientation
Download: https://vimeo.com/706536015/865908db87
Download: https://vimeo.com/706536114/89605a06dc
Download: https://vimeo.com/706536240/2dbab35fea
__Lecture 9: Fundamentals_Manufacturing
Caption Examples
Our vision: We believe top healthcare should be available on an all-inclusive global level. No matter who you are or where you're from, world-class healthcare should be available to you | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
As a bold, outward-facing & inspiring statement, our quality policy incorporates our vision & mission, which helps us create measurable objectives | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
A quality policy is not a tick box exercise. It is an affirmative statement of your organization's values. Use this as an opportunity to inspire people both inside & outside your organization | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Ein gweledigaeth: Credwn y dylai'r gofal iechyd gorau fod ar gael ar lefel fyd-eang hollgynhwysol. Does dim gwahaniaeth pwy ydych chi neu o ble rydych chi'n dod, dylai gofal iechyd o safon fyd-eang fod ar gael i chi | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Fel datganiad mentrus, allblyg ac ysbrydoledig, mae ein polisi ansawdd yn ymgorffori ein gweledigaeth a’n cenhadaeth, sy’n ein helpu i greu amcanion mesuradwy | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Nid ymarfer ticio’r blychau yw polisi ansawdd. Datganiad cadarnhaol ydyw o werthoedd eich sefydliad. Defnyddiwch hwn fel cyfle i ysbrydoli pobl oddi mewn ac oddi allan i'ch sefydliad | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733154004/1f23743ff7
Download: https://vimeo.com/733154137/15233cc4a3
Download: https://vimeo.com/733154385/f638a4ef87
Vertical orientation
Download: https://vimeo.com/733155301/b9656b6803
Download: https://vimeo.com/733155399/3e02bfa982
Download: https://vimeo.com/733155602/84dad27c47
Lecture 10_Fundamentals: Materials
Caption Examples
In the Custom Medical Devices: Device Design short course, we cover materials used for manufacturing implants and surgical cutting guides. With the fundamental knowledge of material properties, we can create effective devices for our patients.
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Caption Examples - Welsh
Yn y cwrs byr Dyfeisiau Meddygol Personol: Dylunio Dyfeisiau, rydym yn ymdrin â deunyddiau a ddefnyddir ar gyfer gweithgynhyrchu mewnblaniadau a chanllawiau torri llawfeddygol. Gyda'r wybodaeth sylfaenol am briodweddau materol, gallwn greu dyfeisiau effeithiol i'n cleifion.
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Horizontal orientation
Download: https://vimeo.com/863078930/4b5fe1d54a
Download: https://vimeo.com/707745978/58d335499e
Download: https://vimeo.com/707746049/1ec3871775
Vertical orientation
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__Lecture 11: Fundamentals_Materials Testing
Caption Examples
Custom medical devices are life-changing. Managing resources can help make these services more cost-effective and safer, leading to a greater number of benefits for more people | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Resources are the most significant investments for organisations, encompassing finances, staff, equipment, physical space, technology and time | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Resource management allows your organisation to react effectively to the needs of patients & medical teams. Whether you're part of a large or small team, organisational resources are precious | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae dyfeisiau meddygol wedi’u teilwra’n newid bywydau. Gall rheoli adnoddau helpu i wneud y gwasanaethau hyn yn fwy cost-effeithiol a mwy diogel, gan arwain at fwy o fanteision i fwy o bobl | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Adnoddau yw'r buddsoddiadau mwyaf arwyddocaol i sefydliadau, sy’n cynnwys cyllid, staff, offer, gofod ffisegol, technoleg ac amser | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae rheoli adnoddau’n caniatáu i'ch sefydliad ymateb yn effeithiol i anghenion cleifion a thimau meddygol. P'un a ydych yn rhan o dîm mawr neu fach, mae adnoddau sefydliadol yn werthfawr | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/707768088/676cda1f48
Download: https://vimeo.com/707768274/4767440faf
Download: https://vimeo.com/707768456/cbfa535e55
Vertical orientation
Download: https://vimeo.com/707769947/d3a2b24de7
Download: https://vimeo.com/707769947/d3a2b24de7
Download: https://vimeo.com/707770386/e94028dec7
__Lecture 12: Fundementals_Design for manufacture and human factors
Caption Examples
Preparing for the unexpected & preventing harm before it occurs, is a central theme in risk management. Let’s discover how to identify, evaluate & reduce the impact of these risks | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Failure Modes, Effects & Critical Analysis, or FMECA, is a risk assessment tool to help detect & manage risks associated with your medical device or process, we use a process FMECA | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Systematically evaluating & controlling risks forms the backbone of risk management activities, which helps to safely bring the benefits of custom medical devices to a greater number of people | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae paratoi at yr annisgwyl ac atal niwed cyn iddo ddigwydd yn thema ganolog mewn rheoli risg. Gadewch i ni ddarganfod sut i nodi, gwerthuso a lleihau effaith y risgiau hyn | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Adnodd asesu risg yw Dulliau Methiant, Effeithiau a Dadansoddi Beirniadol, neu FMECA, i helpu i ganfod a rheoli risgiau sy'n gysylltiedig â'ch dyfais neu’ch proses feddygol, rydyn ni’n defnyddio FMECA proses | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Gwerthuso a rheoli risgiau’n systematig yw asgwrn cefn gweithgareddau rheoli risg, sy'n helpu i gyflwyno buddion dyfeisiau meddygol wedi’u teilwra i fwy o bobl mewn modd diogel | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/734789669/4ba5ee87d2
Download: https://vimeo.com/734789769/76419b762a
Download: https://vimeo.com/734789951/f453d93e17
Vertical orientation
Download: https://vimeo.com/734794159/f6615df9ad
Download: https://vimeo.com/734794252/5475a52e4a
Download: https://vimeo.com/734794375/468b18f7da
__Lecture 13: Fundamentals_Segmentation
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4
__Lecture 14: Fundamentals_Surgical Tools Library
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4
__Lecture 15: Fundamentals_Importing into Freeform
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4
__Lecture 16: Design_Orbital Floor
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4
__Lecture 17: Design_Cranioplasty Plate
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4
__Lecture 18: Design_Zygomatic + complex craniofacial
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4
__Lecture 19: Design_Fibula Freeflap
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4
__Lecture 20: Clause 8 Customer Feedback/post-market surveillance
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4
__Lecture 21: Clause 8 Non-conformance & CAPA
Caption Examples
The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
To create technical files for medical devices, separate them by their intended purpose, like orbital floors and cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS
Caption Examples - Welsh
Mae diogelwch a pherfformiad dyfeisiau meddygol o'r pwys mwyaf, gadewch i ni edrych ar sut mae ffeiliau technegol ac adroddiadau gwerthuso clinigol yn creu corff o dystiolaeth i hwyluso adolygiadau rheoleiddiol | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Er mwyn creu ffeiliau technegol ar gyfer dyfeisiau meddygol, gwahanwch nhw yn ôl eu pwrpas bwriadedig, fel gwaelodion creuol a phlatiau cranioplasti; bydd angen ffeil dechnegol arnoch ar gyfer pob is-gategori dyfais | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Mae creu ffeiliau technegol, gwerthuso clinigol a rheoli risg wedi'u cydblethu'n glòs; maen nhw’n cynnwys yr holl dystiolaeth i brofi bod eich dyfeisiau meddygol yn ddiogel i'w defnyddio | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr
Horizontal orientation
Download: https://vimeo.com/733160355/ef7cd3053c
Download: https://vimeo.com/733160532/e661b7ecd2
Download: https://vimeo.com/733161468/8428e259d6
Vertical orientation
Download: https://vimeo.com/733168179/4cbf0f5393
Download: https://vimeo.com/733168282/4d1d8ffb76
Download: https://vimeo.com/733168509/d6d66ab9c4