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 […]
Documentation of QMS processes, quality events, and workflows is critically important. Sometimes the notion of documentation can create angst within a company. Sometimes the idea of documentation is viewed as overly burdensome and often times unnecessary with little value added. In my experience, most companies do create quite a few burdens and obstacles regarding documentation. […]
“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 […]
How do you manage your Quality Management System? If you are like the majority of the medical device industry, chances are you have a QMS that is a combination of paper-based processes and general purpose tools, loosely held together by a group of people within your company–usually document control. Maybe you are using Excel or […]
EU regulations require manufacturers to produce a PMS plan as part of their technical documentation. The plan must be implemented to produce PMS reports (PMSRs) or Periodic Safety Update Report (PSURs) depending on the class of the device. PMSRs apply to class I medical devices under the MDR, and to class A and B devices […]
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 […]