Sam Bacon

Consultant
I have nearly three years’ experience working with a number of medical device clients to develop and implement the following:
Quality Management Systems (QMS) to ISO 13485:2016 compliance including Class I, IIa, IIb and SaMD
Technical File Summary Reports to MDD 93/42/EEC (as amended within 2007/47/EC) and the new MDR including Class I, IIa, IIb and SaMD
510k Submissions, MDSAP Projects, PMS and CER Reports
Development of supporting documentation for Technical Files such as
Risk Management Plans / Hazard Identification / FMEAs / Risk Management Final Reports to ISO 14971:2019
Essential Requirements Evaluations to Annex I of MDD 93/42/EEC
GSPR Evaluations to Annex I of MDR 2017/745
Device classification according to both the MDD and the MDR including SaMD
Device labelling / artwork in compliance with CE Marking requirements.