In this webinar, Erwin Waas will explain the legal requirements arising from EU regulations for medical devices. The session will focus specifically on Post-Market Surveillance (PMS): an essential component for any organization active in medical devices or healthcare-related software applications.
The European Medical Device Regulation (MDR) imposes strict requirements on the quality, safety, and market surveillance of medical products. These requirements apply not only to physical devices but also to software applications used in healthcare.
During the webinar, Erwin Waas will provide insight into the legal obligations arising from this legislation. A key component discussed in detail is Post-Market Surveillance (PMS): the mandatory, continuous process of monitoring products after they have been placed on the market.
Post-Market Surveillance involves planning, executing, and reporting activities that provide valuable insight into the performance and safety of a device in practice. A well-designed PMS process helps organizations stay compliant with the market, identify risks early, and continuously improve products.
Curious how you can implement this within your organization?
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Regulatory and Quality Manager Medical Devices at Dawn Technology
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