Webinar

Free Webinar | Getting IVD Software into Byte Size Pieces

June 17, 2021

Date: June 17th, 2021

Time: 11:30am-1pm ET | 17:30-19:00 CET

Location: Virtual

Language: English

PresentersCoenraad Davidsdochter & Sue Spencer

Introduction:

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. 

Learning Objectives:
  • 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

Coenraad Davidsdochter
Sue Spencer
Post date: April 28, 2021
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