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…
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.