×

You're moments away from product development success!

First Name
Last Name
Company
Industry
Country
State
Province
Pending Opt-In
All fields are required. Your privacy is important to us.
Thank you!
Error - something went wrong!

An Overview of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR)

Looking to stay ahead of ever-evolving regulations governing medical devices? 

In this webinar, we discuss the continual rollout of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) and the impact they're having on the medical device industry.   

Vincent Balgos, Director of Medical Device Solutions at Jama Software and Saby Agai, Sr. Consultant at Jama Software, provide a high-level overview of the new regulations, along with general industry observations and future considerations for organizations with medical products marketed in the EU market area, including:   

  • New classifications, grandfathering clause, and risk management requirements  

  • The number of notified bodies, backlog, and remediation efforts for placed products  

  • Future considerations regarding the compliance compatibility of IVDR & FDA and traceability  

Finally, learn how the Medical Device Framework in Jama Connect® can help streamline your compliance efforts and ensure your products meet all the necessary regulatory requirements. 

Previous Video
New Research Findings: The Impact of Live Traceability™ on the Digital Thread
New Research Findings: The Impact of Live Traceability™ on the Digital Thread

In this webinar, unlock industry research findings on the digital thread - the best approach for product de...

Next Video
Why it Makes Sense to Store Cybersecurity Risk Management Items Inside a Requirements Management System
Why it Makes Sense to Store Cybersecurity Risk Management Items Inside a Requirements Management System

In this webinar, learn more about Threat and Risk Analysis (TARA), its importance in achieving ISO 21434 co...