Developing Software as a Medical Device

Pioneering software that’s used in hospitals and homes near you

Do you have an idea that could improve health and care services but not sure how to implement it? Do you have a digital health prototype but unsure how to productise it? Are you struggling to achieve ‘product-market fit’ rolling out your software as a medical device (SaMD)? 

If you are looking for a software development partner to help design, build and roll out your digital health medical device, you’re in capable hands with 8fold Governance. 

With over three decades of combined experience in UK medical health and tech software development, our team has built a track record of successfully producing ISO 13485 compliant software that can be scaled for millions, while procuring regional and national contracts across the UK.


Software as a Medical Device


Software Designed for the NHS


Our specialist Development team has spent years embedding and contributing to the design of NHS and international software design standards, such as FHIR APIs. It’s this knowledge and experience that has allowed us to create pioneering digital health innovations that are making a real difference for patients and professionals in the NHS.                                 

We specialise in interoperability (FHIR/ HL7), EMR integrations (EMIS, SystmOne), SSO, OAuth2.0, Software as a Medical Device (CE/ UKCA/ FDA) and coded data (LOINC, SNOWMED, DM+D).

Full-Stack Development

Using this industry standard development expertise, we support the design and delivery of digital health software solutions – covering all aspects of care delivery and management. We build mobile apps, video conferencing, and even algorithms for artificial intelligence solutions. That’s everything from chronic disease management apps, integrated care solutions, medical analytics software for population health management, to security, and much more.


Software - 8fold Governance

Software Development NHS


Product Management and Strategy

A successful product combines technology and design to solve real customer problems. Product management is the act of making this happen. We’ve been there – and successfully come through the other side. And in the process, we have created ‘Go-To’ market strategies that help our clients to achieve their own goals.

The 8fold Product Management team works with our clients to develop a detailed understanding of the problem, before designing and developing software solutions that meet user needs. This team is led by Shailesh Suri – a medically qualified doctor specialising in acute clinical medicine and public health. Shailesh has supported a personal health records (PHR) software-as-a-service (SaaS) pioneer to grow from an early start-up, to the most successful PHR company in Europe and the UK, with national and regional level NHS contracts – and together, we look forward to doing this for you.

Specialists in Medical Device Regulations

As an organisation founded in information governance and clinical safety (DCB0129) for the NHS, we build software to the highest governance standards expected of health IT systems in the UK. 

Our highly experienced team has a track record of successfully developing NHS DTAC compliant Software as a Medical Device (SaMD) products and applications. Our integrated approach guarantees that our clients deliver on the ISO quality standards, including ISO 13485 (Medical Devices) and ISO 14971 (Risk Management) – in partnership with the very best members of the International Register of Certificated Auditors.

Medical Device Regulations


Our Services

Our support doesn’t just stop when your product has been developed. We support all aspects of the product life-cycle. That means streamlined support and industry-wide partnerships that will take your product from concept, all the way through to market penetration. 


Strategic & Commercial Partnerships

Lean on our extensive networks, along with our knowledge of the NHS and digital health market to improve patient outcomes and forge commercial and strategic relationships.

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Clinical Risk Management & Clinical Safety Officer as a Service

Meet the mandatory requirements for Health IT System Suppliers to the UK – DCB0129 & DCB0160

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Clinical and Regulatory Consulting

Quality Management and Standards (QMS) for the medical device, software as a medical device, IVD, medical technology and digital health sector including ISO13485.

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Information Governance

Consultancy and outsourced services available including DSP toolkit support, data protection, GDPR assessments, DPIA’s and ISO standard reviews.

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Communications, Branding & Marketing

From branding and product launches, to social media management, reap the benefits of an experienced in-house healthcare marketing and digital tech specialist, with over two decades of experience communicating with the NHS.

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Bid & Grant Writing Services

We’ll support you with identifying, bidding on, writing, and winning contracts across health and social care.

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Cyber Essentials

Pass first time with our platform that guides you through a step-by-step process to achieve your Cyber Essentials and Cyber Essentials Plus Certification. 

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Software & Product Development

Get tailored support with all aspects of your product development from our experienced team of clinicians, developers and product managers.

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Data Security & Protection Toolkit

Designed for organisations with limited or no experience with the DSPT requirements, we’ll review your existing Data Security arrangements and provide guidance on how to ensure your application is compliant with DSPT standards, and help produce all the documentation required to complete online submissions.

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Cyber Security

Is your organisation compliant with cyber security best practice? We’ll help your organisation to securely operate and combat the increasing cyber security threats to avoid damage and disruption to your service. We’ll start with our security health check assessment to provide a comprehensive analysis of the current level of risk, and highlight gaps where your organisation is exposed.

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Get in touch

Why not get in touch for a free, no-obligation call to discuss your project? Simply book a time that’s convenient for you below.

What Our Clients Say

When we have a problem to solve or a complex issue to untangle around IG Adam is there to support us through it. Working with the 8fold team has made our lives a lot easier and built capacity within our team

Marc Singh Jones

The team are pleasant, extremely knowledgeable, thorough, prompt in responding to queries and keen to help in any way they could. The work completed on our behalf definitely exceeded expectations.

Michelle Whitham
NHS Thanet CCG