Hanfodion:

Sut i Mewnforio Eich Data i Mewn i Freeform

Overview

Importing 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
Further Reading

Relevent research paper links / citations
Attributions

CT scanner videography by RhPAP is licensed under CC BY 3.0

Lecture 1: Custom Medical Device Design

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: ISO 13485 Quality Management System

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/704584867/eb47dca4d4

Download: https://vimeo.com/704584987/f614bafef5

Download: https://vimeo.com/704603696/b376f65b3a

Lecture 3: Device Classification

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: Documents and Records

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: Risk

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: Management Responsibilities

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: Quality Manual

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: Scope

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: Quality Policy

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: Quality Objectives

Caption Examples

Goal setting is universal. We set goals for our careers, well-being & general life. We'll explore how to write clear and focused goals and ways of tracking if we're getting better or worse | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS

Quality objectives are significant goals or targets; they're action orientated, inspiring & help us achieve continual improvement in our QMS & organisation | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS

Identifying what success looks like to your organisation & tracking progress gives insight into which processes aren't working well. Goals provide clarity and actions, which lead to success | study Custom Medical Devices with @cardiffmet @pdr_spd | @PDR_Design @CardiffMetCSSHS

Caption Examples - Welsh

Mae gosod nodau’n hollgyffredinol. Rydym yn gosod nodau ar gyfer ein gyrfaoedd, ein lles a’n bywyd yn gyffredinol. Byddwn yn archwilio sut i ysgrifennu nodau eglur ac sydd â ffocws, a ffyrdd o olrhain a ydym yn gwella neu'n gwaethygu | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr

Nodau neu dargedau arwyddocaol yw amcanion ansawdd; maen nhw’n canolbwyntio ar weithredu, yn ysbrydoledig ac yn ein helpu i gyflawni gwelliant parhaus yn ein SRhA a'n sefydliad | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr

Mae nodi sut beth yw llwyddiant i'ch sefydliad ac olrhain cynnydd yn rhoi cipolwg ar ba brosesau nad ydynt yn gweithio'n dda. Mae nodau'n darparu eglurder a chamau gweithredu, sy'n arwain at lwyddiant | astudiwch Ddyfeisiau Meddygol Wedi’u Teilwra gyda @MetCaerdydd @SPD_PDR @dylunio_pdr

Horizontal orientation

Download: https://vimeo.com/707745875/d8d611d7a0

Download: https://vimeo.com/707745978/58d335499e

Download: https://vimeo.com/707746049/1ec3871775

Vertical orientation

Download: https://vimeo.com/707749909/09a7c376ac

Download: https://vimeo.com/707750025/60bd4012d6

Download: https://vimeo.com/707750098/b7d019a62b

Lecture 11: Resources Management

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/707770386/e94028dec7

Lecture 12: Failure Models, Effects and Critical Analysis

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: Technical Files

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