Validation Gaps That Kill Launch Timelines
Published on: 25/12/2025
Validation is a critical component of quality management that ensures medical devices are safe, effective, and compliant. For MedTech innovators, gaps in validation
Quality Culture
Case Study: QMS Gap Assessment and Integration
Published on: 08/12/2025
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.
Quality Culture
Understand What Is the Risk Management Plan (RMP) and Risk Management File (RMF)
Published on: 01/10/2025
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.
Quality Culture
Companies With Strong Quality Cultures Resolve Issues 25% Faster
Published on: 29/09/2025
Research and practical experience show that companies with strong quality cultures consistently resolve issues up to 25% faster than those without.
Quality Culture