Medical device regulations such as ISO 13485 and global authority requirements place strong emphasis on systematic control of design, manufacturing, and post-market activities. A compliant QMS begins with well-defined processes supported by clear documentation, effective training, and strong management oversight.
Beyond documentation, regulators expect organizations to demonstrate consistent execution of processes, including design controls, risk management, supplier qualification, and change management. Post-market surveillance, complaint handling, and CAPA effectiveness are key areas of inspection focus. By implementing a risk-based and scalable QMS, medical device companies can ensure regulatory compliance while supporting product quality, patient safety, and sustainable business growth.
