Japan’s PMDA Remote Inspections

The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.

QMS Implementation for Class I Devices Under EU MDR

  OVERVIEW The European parliament had signed off second round of corrigenda in December 2019 considering mounting pressure from device manufacturers, notified bodies and industry associations. The notified bodies have been receiving large number of applications for CE marking in order to comply with May 2020 deadline issued for MDR. However, the corrigenda may postpone […]