Medical Device Software is Evolving

The regulatory landscape for Software as a Medical Device (SaMD) is evolving rapidly. The traditionally conservative medical device sector, which has necessarily had a culture of making changes in a slow and considered manner, thereby ensuring patient safety, clashes with the fast moving world of agile, mobile and cloud service based software. Consequently, software that 5 years ago would have not been classified as a medical device by regulatory bodies, is now a medical device and subject to much more stringent control than before. This presents many challenges for the various stakeholders who may be involved in the SaMD market, particularly new entrants, established medical device manufactures and users of SaMDs.

New Entrants

There are many opportunities for new entrants offering purely software medical devices. The challenge for them is the need to meet unfamiliar and evolving regulatory requirements, so that they can derive income from their products while remaining within the law and mitigating and potential liability issues should their products be at fault in the event of an end user being harmed.

Established Manufactures

Established medical devices manufacturers are also presented the challenge of having processes in place for SaMD products that work with or complement their existing products, where the timescales for development and applying changes needs to be much shorter than they are used to in order to benefit from opportunities in the SaMD space.


Users of SaMD, particularly public and private sector healthcare providers are struggling to understand how they should manage the procurement and operation of SaMDs, while meeting their responsibility to care for their patents in a regulatory compliant manner.

What Can We Offer?

With over 30 years’ experience of software and medical device technologies, Software Medical Devices are well placed to support suppliers and consumers journeying into the emerging world of Software as a Medical Device (SaMD). For manufactures, we re able to help you set up and operate the processes and frameworks required to achieve regulatory compliance when using modern, agile approaches to cloud, web and mobile medical devices software development. For end-users, we are able to help you with procurement and audit processes relating to web, cloud and mobile medical software applications, thereby ensuring that you meet your regulatory requirements.


Feel welcome to contact us via any of the following channels to discuss further how we can help you with software medical device journey.

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