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Welcome to our Library of Regulatory, Certification Information and Updates in the Medical Device Area

Switching your Notified BodyEven though it may seem counterintuitive, it is quite simple to change notified bodies (NB).

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CE Marking of Own Brand Label Devices ManufacturerCompanies often seek to rebrand existing medical devices and sell them under their own name. This process is called Own Brand Labeling and offers faster market entry for companies wishing to build and complete their product portfolio compared to developing a new product.

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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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MDSAP Prepare the transition, worldwide market access

clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Certification Project Manager - In Vitro Diagnostics responsible for medical device manufacturing clients.