Programme of study for software as a medical device

A course of study to support professionals needing to gain regulatory approval for a piece of software as a medical device, who do not have previous regulatory experience.

Is your software a medical device?

The term Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

If your software is a medical device, and if you have no previous training in healthcare regulatory affairs, the following course of training will help you understand the requirements and how to meet them.

This training is designed as a complete package, not all of it focusses on software as a medical device; the initial courses are designed to introduce the basic principles and concepts of the regulation of medical devices, which is needed to fully understand the requirements for software as a medical device.

Essentials of European Medical Device Regulatory Affairs

4 May 2022 | London, UK and online

This face-to-face course will provide an overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment.

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The Medical Device Introductory Course

5–7 July 2022 | London, UK and online

(Module 13 of the MSc Medical Devices) Providing those new to Medical Device Regulatory Affairs with an understanding of the regulatory requirements for medical devices in the EU.

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Understanding Digital Health and Electronic Products

1 September 2022 | London, UK

This course covers regulatory requirements for electrical, electronic, and software devices including current guidance, interpretation, and application of regulations. The practical considerations of design, development, and placement on market for these type of active devices will be discussed. In particular, the regulation and approval of software devices is particularly challenging with limited guidance available with continual advancement of technology.

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Design, Development and Certification of Medical Devices

23–25 March 2022 | London, UK and online

This Masterclass is also module 14 of the MSc Regulatory Affairs and will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.

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If you want to understand whether your software would be classed as a medical device you can start with these resources: