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Over 15 years’ experience within Medical Device Regulatory, with 10 years of those in Consultancy. Specialising in single use, sterile devices due to a strong microbiology background (>20 years). Involved in numerous successful CE marking projects ranging from class III to self-registration class I devices for European submissions along with US and Canadian registration and submission. Implemented, managed and audited numerous ISO 9001, ISO 13485, US 21 CFR 820, JPAL Quality Management Systems. Qualified Internal Auditor and Responsible Person Specialist for Cosmetic products.

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