Product Labeling for Medical Devices is an essential part of the certification process and the technical documentation. It involves...

EU AI Act and Medical Devices:  The European regulation for artificial intelligence must also be applied to medical devices. With Prof....

SN EN ISO 13485/A11:2021 Medical devices — Quality management systems — Requirements for regulatory purposes Amendment 11 SN EN ISO...

In the medical device industry, balancing compliance costs  with the need for speed and innovation is a constant challenge. How does your...