Medical Device Postmarket Surveillance (PMS) Training
Regulatory bodies are increasing their focus on postmarket surveillance (PMS), as evidenced by the more stringent requirements of the EU MDR and IVDR and the establishment of PMS as a core process within the MDSAP program. In this class, you will learn practical steps for collecting, analyzing, reporting, and applying postmarket data, as well as how to connect the PMS process to QMS and risk management processes. Using the ISO/TR 20416:2020 guidance as a foundation, you'll gain the knowledge and skills to establish and maintain a postmarket surveillance system that conforms to ISO 13485:2016 and ISO 14971:2019 and also satisfies the regulatory requirements of EU MDR and IVDR, MDSAP, and other country-specific stipulations.