Navigating MDR compliance for medical device software - IEC 62304

Join us for a session on IEC 62304, focusing on MDR technical documentation for medical device software.

We are pleased to invite you to our upcoming webinar, “Navigating MDR compliance for medical device software - IEC 62304.” This session marks the final installment in our Medical Device Regulation (MDR) webinar series, building on the success of our previous webinars in April and June 2024.

Date       : Wednesday, 16 October 2024
Time       : 14:00 - 15:00 KST
Place      : Online
Speaker  : Kim Jin Ho, Medical Device Auditor & Assessor
 
Agenda:
  • Definition and classification: Detailed exploration of how medical device software is defined and classified under MDR.
  • Medical software lifecycle processes: In-depth discussion on the essential processes involved in the medical software lifecycle.
  • Cybersecurity requirements: Comprehensive overview of the cybersecurity requirements mandated by MDR.

Why Attend?

As an accredited Certification Body for ISO 13485 and a Notified Body of EU MDR, we will offer valuable insights into:

  • Detailed understanding of the IEC 62304 standard and AMD1:2015.
  • Best practices for documenting the software development process to meet MDR requirements.
  • Comprehensive guidance on ensuring your medical device software complies with MDR regulations.

If you are unable to attend but are still interested, please register, as we will send the webinar recording to all registrants after the session concludes. We look forward to engaging in interactive discussions and providing valuable insights to all participants.

We look forward to your participation and to providing you with valuable insights and interactive discussions.

Register your interest now.