To sell and market your medical device across the European Union (EU), you must have a CE marking of conformity. Manufacturers of medical and in vitro diagnostic devices that wish to be part of the European Economic Area market must adhere to regulatory...
The Medical Device Single Audit Program (MDSAP) provides medical device manufacturers an option for a single audit that satisfy the regulatory requirements of five participating countries (Australia, Brazil, Canada, Japan, USA), and allows medical device companies to...
Let’s imagine that your medical device company, headquartered in Nurnberg, Germany, has designed an innovative and award-winning, extended vision foldable, presbyopia-mitigating, intraocular lens (IOL) for use by patients undergoing cataract surgery. This device will...
Imagine yourself in the shoes of a lead clinical investigator or a seasoned product manager assigned to plan and kick off a clinical trial. Many questions will arise, and you will encounter various obstacles which are not only limited to collecting and organizing...
The tough part for the medical device industry is that this landscape of regulations is constantly changing, and therefore, intimidating. The European Union’s Medical Device Regulations (EU MDR) which came into effect on 26 May 2021 after a three-year transition...
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