In the development process, assessing risk is a “best-guess” e ffort. Once you’ve launched your product, you now have confirmation that you’ve captured the appropriate risks and acceptability, since feedback and complaints are captured in the same single system that handles risk management. Fully understand everything that is impacted by a complaint. If there is a […]
Feedback in any form is a good thing. Most companies don’t have the mechanisms in place to collect feedback today so it gets lost, and hinders you from optimizing that feedback in a full product lifecycle. There is good stuff coming from your customers. Listen to it and do something about it. Their design suggestions, […]
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 […]
Feedback is about being proactive, whereas a complaint is typically reactive in nature. Feedback is about soliciting information to confirm that customer requirements have been addressed. Define procedures for gathering this feedback. And I encourage you to do so for all customer types for your products. Realize that the feedback you get may be positive, […]
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 […]