MDR Expert - ISO 13485 QMS - ISO 14971 - ISO 9001

Total Quality Management, ISO 9001 , ISO 13485, MDR, EU AUTHORIZED REPRESENTATIVE, UKCA, Clinical Evaluation Reports, PMS etc
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• DIN EN ISO 13485
• DIN EN ISO 9001
• EU MDR
• FDA
• MDR

Experienced Regulatory Affairs/ Quality Assurance Consultant and ISO 9001 Certified professional,with a demonstrated history of working in the medical device MDR 2017/745,FDA In-Vitro Diagnostics IVDR. Strong legal professional skilled in QMS Tools, Technical Documentation, Management, Leadership, Product development and EU Marketing.

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