-
Welcome! 0 hr 1 min
-
Session Recording 0 hr 47 min
-
Presentation Slides 0 hr 5 min
-
Conclusion 0 hr 1 min
CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
This presentation will provide an overview of the technical documentation requirements under MDR including format and content.
This presentation will provide an overview of the technical documentation requirements under MDR including format and content. Changes from MDD will be highlighted throughout the presentation, as well as any differences in content or level of detail required based on device classification. A brief overview of the application and review process with the Notified Body will also be provided, as well as provide insight into other requirements that will be used to support the submission (including CER, PMS and PMCF).
Presentation Take-aways:
- Understand technical documentation requirements under MDR
- Understand the submission and review process with the Notified Body
- Understand the relationship between Technical - - Documentation and other supporting documentation.
This website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Privacy Policy and other Terms and Conditions at https://www.greenlight.guru/legal-info.
×