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Gemarmed’s Training

Founded in 2010, Gemarmed provides domestic and international regulation administration as well as quality assurance services. By implementing its expertise and understanding of QA & RA system requirements, Gemarmed has been successful in assisting medical companies pass the FDA, CE, and other application processes.

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Become PRRC

Person Responsible for Regulatory Compliance (PRRC) HomePagesEnsure EU regulatory compliance through the Person Responsible for Regulatory Compliance (PRRC)The Person Responsible for Regulatory Compliance (PRRC) is a new requirement of the…

CE Mark – IVDR

In Vitro Diagnostics and the IVDR HomePagesWhat are In Vitro Diagnostics?In Vitro Diagnostics (IVDs) are devices and accessories that perform tests on specimens derived from the human body such as…

Integrate QA & Development

Integrate QA & Development HomePagesWhy should Quality Assurance (QA) and development be integrated?The fierce and intense cut-throat market requires companies to release their products to the market as quickly as…

Medical Device

What is the definition of a medical device? Each regulatory body or regulation such as the FDA or the European Regulation (MDR) will have its own definition of…