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Medical Device Software: Complying with the MDR & FDA Regulations

Management Forum
Course summary
3 days
1,549 - 1,849 GBP excl. VAT
English
Professional Training
Next available date: 28/04/2021 - Online courses
Course Dates
Online courses
1,549 GBP
28/04/2021

Online courses
1,549 GBP
27/10/2021

London
1,849 GBP
03/11/2021

Medical Device Software: Complying with the MDR & FDA Regulations

Course Overview


This intensive three-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.

PLEASE NOTE DAY 3 CAN BE BOOKED AS A ONE DAY COURSE, PLEASE CONTACT US IF YOU WOULD LIKE TO TAKE THIS OPTION ON: info@management-forum.co.uk

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

Who Should Attend?

  • Senior management and project leaders
  • Software product managers, researchers, developers and clinical experts
  • Software development process managers
  • IT managers and integrators
  • Internal and external auditors and/or consultants
  • Regulatory affairs professionals
  • Quality system and quality assurance personnel
  • Technical and medical writers
  • GUI designers

Provider: Management Forum

Management Forum

Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors

Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...


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Contact information for Management Forum

Management Forum

98-100 Maybury Road
GU21 5JL Woking

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Reviews by course attendees

Average rating 4.6

Based on 12 reviews.

Camilla
(4)
A good intensive course - I would recommend for my colleagues especially who need a general understanding of MDR impact on medical SW.
Antoine
(5)
Good course, very interesting and complete overview with speakers that bring the insights of both an ex-auditor and an industry representative.
Ana
(4)
The course is well thought and based on the expert's experiences.
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Reviews
Course rating
(4.6)
Based on 12 reviews.
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