Regulators are becoming much more focused on post-market surveillance and risk management in the medical device industry. Whether you’re seeking regulatory compliance in the United States or European market, standards are quickly harmonizing and it’s important to establish a compliant PMS system to ensure that you can sell your device around the world. On top […]
“A formal system that documents the structure, processes, roles, responsibilities and procedures required to achieve effective quality management.” A QMS is comprised of the core set of business policies, procedures, forms, and work instructions, along with their sequence, interactions, and resources required to conduct business within a medical device company. Quality records are documentation that […]
The Medical Device Regulation 2017/746 (MDR) defines PMS as: All activities carried out by manufacturers in cooperation with other economic operators to institute and maintain a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market, or put into service for the purpose of […]