Medical Devices – Regulatory Updates December Volume 1
Europe | Australia (TGA) | Philippines (FDA) | China (CMDE)
EUROP...
EU MDR Implementation Extension – helps in Compliance Planning
As the extended transition deadline 26 May 2021 is approaching, w...
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 t...
Device Label Externalizing or Outsourcing
If you are single product Device Company or single country multi-...
UDI : FDA versus EU with CND
With increasing concerns for patient safety and efficient supply ...
