The South African Health Products Regulatory Authority (SAHPRA) has given plenty of notice to industry over the last several years...

Understanding ISO 13485 – Made Simple If you're in the medical device industry, you've probably heard of ISO 13485. But what exactly is...

In a groundbreaking development, Dexcom has become the first medical device company to integrate generative AI into a continuous glucose...

The Medical Devices Unit of the South African Health Products Regulatory Agency (SAHPRA) regulates the licencing of medical device...

Intertek Medical Notified Body UK Ltd (IMNB UK) is very pleased to announce we are now UKAS accredited for ISO 13485. The scope of our...