Videos tagged 'Understanding Medical Device Regulation'
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11:52
Welcome and introduction to medical device regulation
December 20, 2021
Introduction from Robin Sayer, Head of Mechanical Engineering, at NHS Greater Glasgow and Clyde's Medical Devices Unit. Robin discusses why it was decided this webinar would be important, covers w...
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06:52
The regulatory landscape
December 20, 2021
Elaine Gemmell, Head of Regulatory Affairs at Scottish Health Innovations Ltd (SHIL), provides an overview of the organisation and it’s role in providing regulatory support and advice before delvin...
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22:07
UKCA v CE
December 20, 2021
Elaine Gemmell, Head of Regulatory Affairs at Scottish Health Innovations Ltd (SHIL), explores how medical device regulation works and compares UKCA v CE marking. Elaine covers the medical device ...
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20:36
Medical Device Definitions
December 20, 2021
Robin Sayer, Head of Mechanical Engineering, at NHS Greater Glasgow and Clyde's Medical Devices Unit, discusses medical device definitions and device classification.
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13:18
Exemptions and Tech Docs
December 20, 2021
Robin Sayer, Head of Mechanical Engineering at NHS Greater Glasgow and Clyde's Medical Devices Unit, explains how some devices may be exempt from medical device regulations before going on to cover...
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30:16
QMS and Post Market Activities
December 20, 2021
Elaine Gemmell, Head of Regulatory Affairs at Scottish Health Innovations Ltd (SHIL), defines quality management systems including manufacturer’s responsibilities, structure of QMS and requirements...
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25:56
Q&A
December 20, 2021
Elaine Gemmell, Head of Regulatory Affairs at Scottish Health Innovations Ltd (SHIL) and Robin Sayer, Head of Mechanical Engineering, at NHS Greater Glasgow and Clyde's Medical Devices Unit answers...