ISO 14971:2019 – Updates & older Version Differences
The third edition of ISO 14971 was finally released in December 20...
Proactive strategies for Devices to minimize disruption
It is know that Medical devices have long as well as highly regula...
IVDR requirements for SOFTWARE
Software fulfilling the definition of an in vitro diagnostic medic...
FDA/EU/MHRA/TGA suggestions for ongoing clinical studies
There are several suggestions, recommendations from different heal...
Real-World Approach in Collecting Clinical Data for MDR & IVDR
The deadline for MDR is drawing near and for IVDR too there is not...
