Software as a Medical Device regulations compliance

Are you are looking at developing a software or hardware medical device and need regulatory advice?

Do you have a digital medical device and need quality and regulatory support?

Do you want to get regulatory approval for your innovative healthcare app?

As the world becomes more connected, the amount of data generated every day continues to increase exponentially. Medical Devices are no different, and medical devices now generate huge quantities of high-quality patient health data and measurements. Leveraging this data for meaningful insights for clinical decisions on patient triage, surfacing clinical indicators and prognosis are high on the agenda for many medical device, IVD and medicines companies looking to improve their product and service offerings. Cutting edge medical devices are now supporting and even automating diagnosis, treatment and preventative decisions to take burdens off healthcare systems.

Regulatory compliance for Digital Health Devices

IMed have highly qualified technical experts familiar with medical device software, hardware, Artificial Intelligence/ Machine Learning and digital health experienced in navigating the complexities of developing software in an agile manner, whilst meeting regulatory obligations for safety, performance and control of changes.

Support in navigating unchartered waters for SaMDs and digital health

We have experience in gaining and maintaining regulatory approvals for highly complex software and AI/ML algorithms for a multitude of international companies.

If you are looking at developing a software or hardware medical device, or need quality and regulatory support with your existing product, get in touch to see how IMed can support you in your journey to getting your medical device or digital health product on the market. 


imed management team

At IMed, we do things a bit differently – investing time in getting to know our clients and their businesses. We value the business they give us of course, but we also respect the trust being shown in IMed whenever we are selected as a regulatory partner.

So just ask us for whatever you need, and we’ll find the best way to deliver it to you. And, if you aren’t sure what you need – just talk to us and we can help with that too!

Please contact us now on 01295 724286 or email us at, so that we can discuss your situation and tell you how we can help you get your products compliant and on sale.

Discover more about registering your device internationally.

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