I have nearly three years’ experience working with a number of medical device clients to develop and implement the following:

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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

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Development of supporting documentation for Technical Files such as

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Risk Management Plans / Hazard Identification / FMEAs / Risk Management Final Reports to ISO 14971:2019

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​Essential Requirements Evaluations to Annex I of MDD 93/42/EEC

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GSPR Evaluations to Annex I of MDR 2017/745

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Device classification according to both the MDD and the MDR including SaMD

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Device labelling / artwork in compliance with CE Marking requirements.