The EU MDR poses tremendous economic and practical challenges for manufacturers. With deadlines looming, lingering ambiguities, and limited availability of notified body support, companies struggle with implementation.
The MedTech Intelligence web seminars assemble key industry experts, notified bodies, and EU MDR consultants to share practical strategies and procedures for EU MDR implementation.
EU MDR Implementation Strategies
February 4-6, 2020
- Economic Operators
- Systems and Procedure Packs
- Labeling & IFU (GSPR 23)
- Implant Card (Article 18)
- Clinical Evaluation
- Software under MDR
- Hazardous materials
- Assignment of Basic UDI-DI
- Article 117 and drug device combination products
- Article 120(3)- Strategies for addressing the unknowns around what product changes can be made...
- PMS under MDR
- Art 88 - Trend Reporting
- Your First experiences with NB MDR audits
- Discussion - Notified Body/Competent Authorities: A Q&A opportunity for the audience to ask questions anonymously
EU MDR Risk Management
April 6-7, 2020
This two half-day virtual event features presentations and panel discussions by speakers from notified bodies and top medical device companies.
- Introduction and Overview - Risk Management and the EU MD
- ISO 14971:2019 – Overview and Applicability to EU MDR and other regions
- Design and Usability Requirements with respect to EU MDR
- Practical application of Risk Management for EU MDR
- EU MDR and Post Market Surveillance Requirements
- EU MDR additional Monitoring and Trending Requirements
- Post Market Surveillance methods and best practices
- Post Market Surveillance and Risk Management
- Application of Risk Management for Post Market Surveillance and Trending
- Tying it all together - EU MDR / Risk Management / Post Market Surveillance
We offer Team, Enterprise and multi-conference discounts. Pricing for each virtual workshop is available on each workshop page.
Veronica Allen, Conference Manager can help you select the right discount plan for you and your organization.