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...
SSCP for Devices: Challenges and Approach
As per EU MDR, for class III and implantable devices (other than c...
6 Best Practices to Navigate and Sustain Regulatory Labeling Compliance
It has always been a difficult task to be compliant with the chang...
