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)
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