Real-World Evidence (RWE) is playing an increasingly important role in global MedTech regulatory decision-making, supporting evidence generation across the product lifecycle, from pre-market submissions to post-market surveillance.
Recent regulatory developments underline this shift, including the FDA’s final guidance on the use of RWE for medical device decision-making and the European Commission’s proposal to simplify MDR and IVDR, both of which have important implications for how real-world data (RWD) is generated and assessed.
This webcast features industry experts: Richard Holborow, Head of Clinical Compliance from Notified Body BSI, Cori Maegley, Vice President, Partnerships Management, MDIC's NEST Initiative, Marcus Torr, Head of Post Market Surveys, Purdie Pascoe and Amelia Hufford, SVP, Clinical and Regulatory Science from 3Aware. They unpack what these changes mean in practice and how MedTech manufacturers can build effective, compliant RWE strategies.
Purdie Pascoe Post Market Surveys expertise
With over 500 surveys conducted in the past five years, we’ve built unmatched expertise across device types and risk classifications.
Whether you need full-service support or help at specific stages, our team ensures you collect the clinical / real world data you need to remain proactive and compliant across global regulations. This focus has earned us the trust of manufacturers worldwide, strong partnerships with notified bodies and continuous repeat business.