Legacy devices: change of definition with the new MDR extension
The new MDR deadline extension brings a new definition for legacy devices, and a list of conditions now applies for them to remain in the market.
Read moreThe new MDR deadline extension brings a new definition for legacy devices, and a list of conditions now applies for them to remain in the market.
Read moreThe depth, breadth and scrutiny on clinical data is much more rigorous; and, it needs to be backed by a thorough literature search.
Read moreRegardless of a medical device class, or it's intended use, design, or even the safety history, the Technical File file is a live document of transparency and safety.
Read moreHow to improve your Clinical Evaluation Report (CER) for MDR compliance and Notified Body certification, here are some tips...
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