The number of regulations, standards, and guidance documents specific to software in or as a medical device (SiMD, SaMD) is substantial and growing. The recent rise in regulatory documents that have been developed and set into force coincides with the sharp increase in SiMD and SaMD development within the medical devices industry.

Over the past few years, many companies that previously developed purely mechanical or unconnected devices with electronics and embedded software (eSW) have started to develop connected devices, apps, and/or other digital solutions. Venturing into this new territory comes with its challenges – with even non-medical apps or digital solutions being regulated under the same principles as medical device software (e.g., in terms of cybersecurity and data protection).

Furthermore, whilst developing the source code for a certain functionality (e.g., in an app) is a reasonable effort, compliantly documenting and testing the source code takes a multiple of this duration, not to mention the time and budget required for ongoing software maintenance. When the effort is underestimated, costs explode, and deadlines are missed.

Brought to you by our Head of Quality and eHealth Dr Dirk Hüber, our latest whitepaper outlines some basics regarding design control for software that will facilitate an understanding of why the regulatory requirements for medical device software are in force, and why they make sense. Within the free whitepaper below we explore:

• The different processes to develop and test software (e.g., the classic waterfall vs the V-model)
• Cybersecurity and data protection requirements for connected devices and software
• The importance of software updates & configuration management
• The regulatory requirements for software taken from external sources, such as off-the-shelf (OTS) software and software of unknown provenance (SOUP), including open-source software (OSS) and free open-source software (FOSS), and the need for ongoing maintenance of these kinds of software
• The aspects to consider when purchasing software – even if it’s free of charge

You can access the full whitepaper at the download button below.

Can’t see the whitepaper? Simply log in, or subscribe to our Knowledge update for full access to all content from our MedTech experts.

To discover more about our Quality and eHealth services, see here, and should you have a design control or digital health related challenge, please do get in touch.