Professional Training
4.5 (29 Reviews)

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Length
4 days
Price
1,999 GBP 1,599 GBP
Next course start
22 July, 2024 (+2 start dates)
Course delivery
Virtual Classroom
Length
4 days
Price
1,999 GBP 1,599 GBP
Next course start
22 July, 2024 (+2 start dates)
Course delivery
Virtual Classroom
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Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

This intensive four-day course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide. The programme will be highly interactive, using real-life examples and state-of-the-art practices identified by Notified Bodies in Europe. There will be in-depth coverage on how to prepare compliant technical file documentation for medical device software products and a review of software specification, risk management, architectures, usability and resulting design documentation. Presentations will also offer practical tips on how to streamline the development process and provide an understanding of the regulatory requirements and how Notified Bodies review technical files.

There will be sessions on the practical implication of risk management and usability and an analysis of the differences between FDA guidance and MDR guidance on medical device software. Software recalls, the use of apps in medical devices, the implications of the new draft usability standard, and advice on how to validate your system design will also be addressed.

Upcoming start dates

Choose between 2 start dates

22 July, 2024

  • Virtual Classroom
  • Online
  • English

9 December, 2024

  • Virtual Classroom
  • Online
  • English

Suitability - Who should attend?

Why you should attend

  • Learn how to qualify and classify software in Europe and the rest of the world
  • Get in-depth understanding of the interpretations of MDR Classification Rules 10, 11, 12, 13, 15 and 22
  • Understand the implications of the MDR and US Code of Federal Regulations for software
  • Gain regulatory guidance on mobile apps, software as a service, cloud computing, artificial intelligence and continuous learning software
  • Learn how to write 510(k) and technical files
  • Get a practical understanding of quality management, design control and how it applies to agile software development
  • Hear the best practices on cyber security, risk management, usability andvalidation
  • Learn the principles of clinical evaluations for software as a medical device
  • Gain an insight into state-of-the-art standards applicable to software

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Reviews by course attendees

Average rating 4.5

Based on 29 reviews.
Reviews are published according to our review policy.
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4/5
Conxi V
17 Oct 2022

Overall I am satisfied. Well organized and good quality of speakers and materials

5/5
Didier G
17 Oct 2022

Very good webinar in term of content, presentation and speakers. Lots of extra material made available by the presenters

5/5
Janine B
17 Oct 2022

This course contained excellent content and speakers. I enjoyed that it was interactive with case studies and quiz exercises to keep engagement up and check understanding.

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