October 20, 2020

[FEATURED] Firms With Rocky MDR Compliance Histories Shut Out Of FDA Adverse Event Program

The US agency has updated its Medical Device Reporting website with information on which products qualify for its Voluntary Malfunction Summary Reporting program for adverse events, and which don’t.

Do you like it?0
October 13, 2020

[FEATURED] Requests For Additional Information During EU Audits – What To Expect And How To Avoid Them

A trend toward additional information demands from EU notified bodies risks delays and additional costs. One regulatory expert comments how the EU expectations are now closer to those in the US.

Do you like it?0