This webinar will provide the background and requirements that medical device manufacturers will need for their technical documentation to meet the requirements of the European Medical Device Regulations (EU MDR). This is designed to set the foundation for your planning of next steps to keep your product on the market in Europe.
It’s time to know the essential EU MDR requirements. It’s also time to plan and act.
The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Your organization needs to be working now to meet these requirements in 2020 and beyond.
Your technical documentation will have to be updated for all of your devices to meet the heightened requirements under the MDR/IVDR.
This webinar will describe what to do now, what to keep your eye on, and real-world examples that show how industry is working through the changes. Interpretations will evolve, but our experts will be able to help you navigate the process.
This session specifically covers the content and expectations of notified bodies and regulatory authorities in Europe for the required technical documentation.
Who should view?
This session is designed for medical device manufacturers who market in the EU and are intending to market devices under the EU MDR/IVDR.
Also, newly appointed medical device companies in areas of cosmetics, cosmetic lights/lasers, colored contact lenses, cleaning and disinfecting solutions, sub-dermal and trans-dermal implants are a good fit for this session.
Job functions include:
About the presenter
Christine Santagate, Director, Boston Operations, R&Q
Christine Santagate, RAC, is a Senior Director at Regulatory and Quality Solutions. Christine has extensive experience in the entire medical device life cycle. This includes significant experience with the Design & Development Process, Design Quality, CAPA, and US/ International Regulatory approval. Christine has managed the development and market clearance of many medical devices, while providing coaching to internal staff. As a graduate adjunct instructor of Medical Device Development Regulations and Law at UMass Lowell, focuses on the quality and regulatory aspects of new product development with a heavy focus on risk management.