Achieving organizational discipline around quality records is a scientific and systematic endeavor that extends across regulatory, operational, and cultural dimensions.
From design controls to clinical evidence, the development of therapeutic goods is a continuous, interconnected process grounded in scientific discipline and regulatory compliance.
Validation is a critical component of quality management that ensures medical devices are safe, effective, and compliant. For MedTech innovators, gaps in validation
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.