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Quality and Regulatory Consultant with over 10 years’ experience in Medical Device Quality Management and Regulatory Affairs. Conversant with the creation, review and approval of technical documentation for both CE Technical Files and 510 (k) submissions.

Qualified Auditor with extensive knowledge of ISO 13485 and FDA 21 CFR Part 820 Quality Systems. Expertise in QMS Gap Analysis and delivering the associated education, development and improvement.

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