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 of that, post-market surveillance is just part of doing good business. An effective PMS strategy alerts you to potential flaws in the design or implementation of your device, exemplifying your company’s commitment to the end user, enabling ongoing improvements and outcomes.