Medical Devices – Regulatory Updates – June Volume 1
1.The AEMPS extends the deadline until May 25, 2021 for the adequa...
ISO 14971:2019 – Updates & older Version Differences
The third edition of ISO 14971 was finally released in December 20...
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...
RAPS – 2019 Regulatory Convergence Round-up by MakroCare
Recently concluded RAPS- 2019 regulatory convergence at Philadelph...
Post-Market Surveillance Planning and Challenges under EU MDR
PMS is a collection of processes and activities used to monitor th...
