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Lunch & Learn: How to gain CE Marking for Medical Device Start Ups

Richard Hall is an experienced QA professional with over 25 years’ experience of developing and manufacturing medical devices & IVD's in a range of companies, from start-up to blue chip international healthcare businesses. His last full-time position was Quality and Design Manager for Bio-Rad Laboratories in the UK which he held for 5 years before starting QMS Consultancy in 2014.

Richard now specialises in supporting medical device start-ups to gain ISO 13485 certification and to CE mark their devices, more recently extending his knowledge to help companies with MDSAP compliance. At this Lunch & Learn, Richard will be covering:

  • Global and local regulations

  • What is CE Marking?

  • Directives are moving to Regulations – the changes and their implications…

  • Product Classification

  • Fundamental techniques of Product Design and Development

  • Structure of a typical Technical File and what’s included

  • ISO 13485 – understanding the standard and how it relates to CE Marking

Lunch will be provided.

Earlier Event: June 17
NHS Navigators Surgery (MEMBERS ONLY)
Later Event: July 1
IPCRU Surgery (MEMBERS ONLY)