This case study explores how Perci Health overcame this hurdle by partnering with 8foldGovernace. By providing expert support, we helped Perci ensure compliance with all necessary standards
Clinical Safety Compliance for Fall Detection Software
When Israel-based Vayyar launched its innovative “Vayyar Care” (VC) platform in the UK, they recognised that success in the UK health and social care market demanded more than just advanced technology. Crucially, it required strict adherence to the clinical safety standards.
While many technology providers selling to social care providers, including those run or funded by local authorities, often overlook it, compliance with DCB0129 is mandatory for any software solution providing fall detection. Vayyar was determined to showcase its commitment to quality and safety to build trust and momentum in its commercial activities.
To successfully navigate the complexities of NHS compliance without compromising their innovation speed, based on our proven experience and recommendations from within the health innovation ecosystem, Vayyar chose to partner with 8foldGovernance.
Vayyar is an Israeli semiconductor company and a global leader in the 4D imaging space. As pioneers in radio-frequency technology, they “see” through objects and monitor environments without cameras. This unique approach allows them to prioritise patient care and fall detection while maintaining a dignity-focused ethos, ensuring privacy is never compromised.
Vayyar’s VC platform, a falls-monitoring solution, was successfully piloted with various local authorities and Integrated Care Boards (ICBs). However, as public-sector organisations, these entities mandate a strict entry requirement:
DCB0129 compliance.
DCB0129 is a clinical risk management standard that manufacturers of health IT systems must evidence to show that their product is safe for use by patients. This is not a nice-to-have but a mandatory standard under the Health and Social Care Act. Manufacturers of health IT systems must provide evidence that their product is clinically safe.
Vayyar needed an external Clinical Safety Officer (CSO) who could translate their technical excellence into the specific language of the NHS, represent them in meetings, and provide ongoing guidance and support for future product updates.
At 8foldGovernance, we work to integrate, not reinvent. We recognise high-growth technology companies often have excellent internal controls; they just aren’t yet mapped to the NHS Standards.
Lily explained the process of integration very well while we were selecting our partner, and also the flexibility & responsiveness around the ongoing assessment for new features was a big factor.
James Webb,
Regional Sales Director -UK, Vayyar Care UK
Working with our Clinical Safety Officers, the strategy was to bridge the gap between Vayyars’ existing safety processes against the DCB0129 framework. We streamlined the process by transforming Vayyar’s existing technical controls into formal risk management documentation, avoiding the creation of unnecessary new paperwork.
8fold provided an excellent level of expertise and provided us with valuable guidance… they provided us with very clear instructions, which allowed us to progress at speed and achieve our deadline.
James Webb,
Regional Sales Director -UK, Vayyar Care UK
In just less than 3 months, Vayyar successfully created their DCB0129 documentation and fully integrated it into its business-as-usual workflows. The results extend beyond just a “check-box” exercise. In a market where many emerging technologies lack legally required safety assurance, Vayyar now stands out as a verified, safe, and trustworthy provider.
It shows the market that we take clinical safety seriously in a market of emerging technologies, and the customer can be assured that our platform goes through rigorous testing. For me, it shows we are serious about safety and expert-designed solutions that our clients can trust
James Webb,
Regional Sales Director -UK, Vayyar Care UK
With the DCB0129 foundation firmly in place, Vayyar is now perfectly positioned to scale across more ICBs and local authorities. As the VC platform evolves with new features, we will continue to provide the flexible, ongoing assessment required to ensure that safety remains at the heart of Vayyar’s rapid innovation.
If you are bringing innovative health technology to the UK market, clinical safety shouldn’t be a barrier to your growth. We specialise in turning complex regulatory requirements into clear, actionable, and scalable workflows.
Don’t let DCB0129 slow your momentum. Let’s get your technology into the hands of those who need it most.
Skip to content
