Regardless 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.

FDA latest guidance for 510 (k) regulatory submissions in an electronic format: eSTAR.

How to improve your Clinical Evaluation Report (CER) for MDR compliance and Notified Body certification, here are some tips...

Explain your device to your health-care users and patients with an updated Summary of Safety and Clinical Performance (SSCP).

Clinical Evaluation Report (CER) updates according to the MDR (EU) 2017/745

EU IVDR 2017/746 will enter into force on the 26th of May 2022: here is all the important juice...

The German Federal Institute for Drugs and Medical Devices, has given a workshop about the Oligonucleotide CMC Strategies for Quality Control. For oligonucleotides, starting materials are very important for the overall control strategy...