Medical Device Software Requirements: A Regulatory Overview

27 January 2022 | Short Online Course


1 day live online training | Starts 10am UK Time

Understand the major challenges when developing medical device software on this short online course


Enrol before 14 January to save 20%



Course Overview


Medical device software is evolving and growing exponentially. An increasing number of devices contain software as part of their makeup. Getting a software device to market and then maintaining it is extremely challenging. Once developed software is constantly changing to stay up to date with the latest operating systems or security issues. Notified Bodies and Regulators want to see how you are maintaining a high-quality product that puts the end user’s safety first.


This training course will provide you with solutions to the regulatory challenges you face when working with software as a medical device. Once completed, you will have the knowledge to know what must be done to meet Notified Body/ Regulatory requirements. You will briefly touch on aspects unique to software in major regulatory/development areas such as clinical evaluations, investigations, labelling, post market surveillance and risk management.

Learn more about how we deliver live online training.


What is included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Key Learning Objectives


  • Understand the basic regulatory requirements for device software
  • Discover the common challenges faced by manufacturers with software
  • Learn how best to overcome those challenges with practical knowledge and advice
  • Gain practical skills for bringing a software device to market
  • Be aware of major development hurdles and how to overcome them
  • Examine the regulatory affairs specifically for software in areas such as labelling, risk management, quality and clinical


Course Outline

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1

27 January | 120 mins | 10am UK

Module 1: Software overview and definitions

  • Is your software a device?
  • Examine the definitions and intended use
  • Review the regulations


Module 2: Bringing medical device software to market

Examine the regulatory requirements to put a medical device software on the market.

  • Examine the Medical Device Regulation (MDR) and FDA systems
  • Engaging with a Notified Body
  • Controlling software suppliers and subcontractors
  • Software traceability
  • App stores and digital distribution platforms
  • Software recalls
Session 2

27 January | 120 mins | 1pm UK

Module 3: Usability and Risk management for medical device software

  • Safety risk management – ISO 14971
  • Usability ISO62366
  • Applying an effective risk management strategy for medical device software
  • Design inputs


Module 4: Development of medical device software

  • Usability
  • Operating environments
  • Cyber security
  • Maintenance
  • Selection of tool chain
  • ISO62304, a practical approach
  • SAMD and embedded software
  • Document structure


Module 5: Maintenance strategies

  • Platforms and keeping up to date
  • Udi maintenance
  • Configuration management
  • What are significant changes


Post market considerations and regulatory maintenance

  • Post-market regulatory requirements
  • Implementation of Post Market Clinical Follow-up for medical device software
  • Successfully bringing together risk management, clinical evaluation and PMS to streamline ways of working

Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.


Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.


Richard has worked on many software related projects for clients helping them achieve regulatory compliance in the EU. In addition, he has delivered both online and classroom training courses on medical device software. He can provide multiple examples and case studies during training, drawing on his extensive industry experience.


The course is designed for professionals who want to learn more about the regulatory requirements of medical device software products such as software-only products, hardware product with embedded software, health apps and medical device software.


These include:

  • Regulatory Affairs
  • Project and Product Management
  • Software Architects
  • Designers and Developers
  • Research & Development
  • Clinical Professionals
  • Usability Experts
  • Cybersecurity Experts
  • Risk Management Moderators
  • Quality and Regulatory Specialists
e-learning options

Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.

Email [email protected] for more information.



Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training