Date: June 17th, 2021
Time: 11:30am-1pm ET | 17:30-19:00 CET
Presenters: Coenraad Davidsdochter & Sue Spencer
In this webinar, we will discuss the role of software in IVD devices and why IVD’s are mentioned in MDR and IVDR. You will also learn what the difference is. As well as, software classification under regulations as a device on its own & as part of an IVD.
- IVD’s are mentioned in MDR and IVDR. Why? What’s the difference?
- Software classification under regulations as a device on its own and as part of an ivd
- Applicable standards including IEC 62304 risk classification
- The software development process; how to fulfill the requirements?
- Notified body expectations
- Transitional provisions; requirements for IVD devices under the IVDR