I'm a global Quality Assurance and Regulatory Affairs specialist with over twenty three years’ experience in the Medical Devices & IVD sectors.
Accredited as an Internationally Certified Principal Auditor, I have been instrumental in Quality Assurance and Regulatory Affairs strategy for large medical device / IVD manufacturers. With an impeccable record, I have successfully guided over 500 clients to ISO, FDA, Canadian and CE compliance with the development and improvement of Quality Management Systems (QMS) and Technical Files.
My extensive knowledge within the Regulatory Compliance and Quality Assurance profession has seen me hold key positions as an Internationally Certified Principal and Lead Auditor.
I am also the Director of my own company European Device Solutions Ltd. We are a professional quality and regulatory affairs consultancy, representing Medical Device businesses and products through the ISO 13485:2016 registration of CE marking, complaint handling and adverse incident report processes.