Join BioOhio member R&Q on March 27 for their Intelligence Series Webinar: Risk Management Updates.
This webinar will provide the background and requirements that medical device manufacturers will need for creating, updating or otherwise remediating the risk management files to meet the requirements of the European Medical Device Regulations (EU MDR), In vitro Diagnostic Regulation (IVDR) and other worldwide requirements. This presentation is designed to set the foundation for your medical device risk management files in alignment with Clinical Evaluation Reports (CERs) to keep your notified body satisfied with the documentation to place their CE mark on your device and keep it on the market in the European Economic Area (EEA).
We sound like a broken record, but it’s true: it’s time to plan your actions to meet the essential EU and other worldwide requirements.
The regulatory changes coming with the new EU MDR and IVDR are significant, potentially impacting your device classification and the need for clinical data. Many manufacturers have realized this and started working on the Clinical Evaluation Reports (CERs). However, equally important is the update of the Risk Management Files for your products. Your organization needs to be working now to meet these requirements in 2020 and beyond.
Your product Risk Management File will need to comply with the requirements of the regulations including: a Risk Management System, Post-market surveillance and conformity with harmonized standards including EN ISO 14971 that is also undergoing revision.
This webinar will describe the steps to plan for these requirements as well as practical actions to take to ensure you won’t have any issues keeping your product on the EU market.
This session specifically covers the content and expectations of notified bodies and regulatory authorities in Europe for the required elements of your risk management system, updates to the risk management files as well as requirements for post-market surveillance.
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: