The QMS gap assessment and integration project demonstrated how systematic evaluation, scientific documentation practices, and targeted training can achieve compliance with PIC/S PE 009 and Annex 3 requirements for radiopharmaceutical sponsors and importers.
Risk Management Plan (RMP) and the Risk Management File (RMF). Although closely related, they serve different but complementary purposes. Understanding how these fit into your broader quality and regulatory system is essential for achieving and maintaining compliance.
Research and practical experience show that companies with strong quality cultures consistently resolve issues up to 25% faster than those without.
ISO 14971: Application of Risk Management to Medical Devices