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

Notified Body Post Market PhaseAs economic belts tighten around the world the medical device industry is one of the hardesthit, as one of the most competitive industries. While competition has increased, medical device recalls around the world have also increased in recent years. European authorities recalled 434 devices in 2008, 611 devices in 2009, and 748 devices in 2010.

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Tech File EvaluationThe technical file is the key to a medical device’s certification for CE marking because it contains the most important information about the device, how it works, how it is manufactured, and how it meets the applicable regulatory requirements.

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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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