EU MDR Implementation Extension – helps in Compliance Planning
As the extended transition deadline 26 May 2021 is approaching, we...
Medical Devices – Regulatory Updates – November Volume 2
Europe | US FDA | Australia (TGA) | Malaysia (MDA) | Japan (PMDA) ...
PMS Planning and Challenges under EU MDR
While Post Market Surveillance (PMS) is mentioned in Annex X of th...
Device Label Externalizing or Outsourcing
If you are single product Device Company or single country multi-p...
UDI : FDA versus EU with CND
With increasing concerns for patient safety and efficient supply c...
Medical Devices – Regulatory Updates – September Volume 2
Europe | US FDA | INDIA (DGFT) | Malaysia (MDA) EUROPE 1.MHRA: Reg...
