Medical Devices – Regulatory Updates – June Volume 1
1.The AEMPS extends the deadline until May 25, 202...
ISO 14971:2019 – Updates & older Version Differences
The third edition of ISO 14971 was finally release...
SSCP for Devices: Challenges and Approach
As per EU MDR, for class III and implantable devic...
6 Best Practices to Navigate and Sustain Regulatory Labeling Compliance
It has always been a difficult task to be complian...
RAPS – 2019 Regulatory Convergence Round-up by MakroCare
Recently concluded RAPS- 2019 regulatory convergen...
Post-Market Surveillance Planning and Challenges under EU MDR
PMS is a collection of processes and activities us...
