ANVISA New Medical Device Regulation RDC 751/2022
On March 1st, 2023, the new RDC (Resolution of the Collegiate Boar...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Apr 2023
USA (FDA) | CANADA (HEALTH CANADA) | EUROPE | SWITZERLAND (SWISS M...
Real-World Approach in Collecting Clinical Data for MDR & IVDR
The deadline for MDR is drawing near and for IVDR too there is not...
SSCP for Devices: Challenges and Approach
As per EU MDR, for class III and implantable devices (other than c...
