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Medical Device Software Requirements: A Regulatory Overview
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Medical Device Software Requirements: A Regulatory Overview

3 June 2025 | Short Online Course

£280.00 – £350.00

(15 customer reviews)

1 day live online training | Understand the major challenges when developing medical device software on this short online course

Register Early To Save

 

Enrol before 9 May to save 20% (June Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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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

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

3 June 2025

1-Day Live Online Training
Register at the top of the page.

25 November 2025

1-Day Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

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

3 June 2025

25 November 2025

 

120 mins | 10:00 AM 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

3 June 2025

25 November 2025

 

120 mins | 10:00 AM 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

15 reviews for

Medical Device Software Requirements: A Regulatory Overview

3 June 2025 | Short Online Course

  1. Eyoto –

    n/a

  2. Spirit Digital (verified owner) –

    n/a

  3. Cyden –

    n/a

  4. Spirit Digital (verified owner) –

    Great course to attend before starting a new product.

  5. Individual Booking –

    n/a

  6. Imed Consultancy –

    Very informative, felt reassured that the speaker had 100% confidence and knowledge in the subject area.

  7. Hirsch Dynamics (verified owner) –

    Was very well organized. The portal access and having access before to the materials was really useful. I don’t think anyone in the world could say this is a super interesting topic! But honestly Richard was so engaging, knowledgeable and interesting to listen to.

  8. Individual Booking (verified owner) –

    I learned about other useful topics that had not been announced in the course

  9. Individual Booking –

    Good course for a general overview of software requirements

  10. Amara Therapeutics –

    n/a

  11. Luminate Med (verified owner) –

    n/a

  12. CMR Surgical –

    n/a

  13. CMR Surgical –

    n/a

  14. University of Nottingham –

    The course was well paced and delivered. I would recommend to others.

  15. University of Nottingham –

    This course was extremely helpful! It covered lots of really detailed information in a really easy and accessible way. I have learned a lot.

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