Preparing Technical Documentation for MDR

Filmed on July 13, 2022 - Learn why you should have technical documentation and what needs to be considered to establish compliance. We discuss some important elements that need to be taken into account, but do not go into specific details of each requirement of the MDR for technical documentation. We do, however, give some key points and explain how NB are looking at your technical documentation. 0:00 Introduction 3:26 Agenda 4:40 MDR Key Changes 12:29 Beyond MDR 14:38 What Needs to be Considered Before Technical Documentation? 16:28 What is Technical Documentation? 24:41 Coding of your Medical Device 33:03 Codes Relationship 35:30 How to Classify your Device 37:55 Life Cycle Approach 40:41 Clinical Approach 45:46 Post Market Surveillance 46:35 Relationship Between Clinical Data 50:30 Notified Body Assessment Team 52:58 How the NB Assess TD 55:07 SGS Academy - Training 56:10 Q&A Speaker Virginie Siloret - Global Medical Device Certification Manager, SGS Learn more: https://bit.ly/45kTABd Follow us on LinkedIn: https://bit.ly/44lmAY1