Sam Bacon

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Consultant

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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.