The EU is conditionally extending the MDR deadline. Medical device manufacturers with certificates approved before 26 May 2021 can extend their validity if their products meet certain conditions, one of which is the establishment of an MDR-compliant Quality Management...
Complying with EU Medical Device Regulation (MDR) is not optional. If you are a manufacturer, authorised representative or distributor of medical devices, you will need to ensure compliance with EU MDR. Non-compliance with biological safety requirements can result in...
After more than a year of dedicated effort and nearly 4.000 hours of preparation, we are proud to announce that we have received the globally recognised ISO 13485:2016 certification from BSI under certificate number MD725842. We chose BSI as our certification partner...
The deadline, 26 May 2021, for EU MDR is fast approaching. The Danish Medicines Agency (Lægemiddelstyrelsen) recently published guidance regarding the new regulations and their consequences for both industry and Danish authorities. Read their guidance here (Danish...
SAXOCON is ready for the EU MDR, are you? 26 May 2021 is the deadline for the full implementation of the new EU MDR (Medical Device Regulation). This will have far-reaching consequences for all medical device manufacturers that want to sell their products in the...
