Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026.
Veeva Vault CRM for Medtech is a unified customer relationship management (CRM) and content management application built for medtech sales teams, key account managers and medical affairs professionals.
The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.
Part III of the series on remediation looks at how companies can tie risk priorities into the remediation process.
A three-part series on quality system remediation and what manufacturers need to do to get through the process.