Frenken Quality Solutions
medical devices
About
As a down to earth and analytical person, I'm offering over 10 years of experience in the medical and non medical field. I have worked in the domains of production, development and in the setup of a QMS environment. Do you want to setup or modify your QMS or need help in the development and/or release of your product to the market, then please feel free to contact me for more information: [email protected] (0031-6-10587978) Specialties: - ISO9001, ISO13485 (Lead auditor) and 21CFR820 - IEC62304, IEC60601, ISO14971, MDD, etc.. - QMS software validation for FDA and EU requirements e.g. Part11, Gamp 5 (Project lead) - EU Medical Device Regulatory Affairs (Certified)
Company Information
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Employees 1
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Founded 2017
Location
Eindhoven, North Brabant, Netherlands, 5611 CB
