Turn safety & compliance into your competitive advantage
Trusted by visionary companies building transformative health technologies
Clinical Safety and Data Protection are not just mandated requirements
They’re opportunities to deliver a more effective and trustworthy product—and differentiate from competitors that cut corners.
Your patients and customers deserve it.
And we can help you get there….fast.
Our Services
We deliver confidence, not just compliance
Clinical Safety
Fast and confident DCB0129 compliance for a new product or feature, required to sell into the NHS.
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Audit of current clinical safety processes and documents with gap analysis
Hazard workshops with your cross functional team
Core document creation (CRMS, CRMP, Hazard Log, Incident Management Log, CSCR)
CATR (Clinical Authority to Release) certificate
Medical device qualification and classification assessment
For medical devices, be ready to meet the clinical risk requirements for ISO 14971
Data Protection
DPIA assessment and advice for a single product or new feature, required for NHS DSPT and DTAC.
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Audit of current data protection processes, documents and data flows with gap analysis
Assessment of your compliance needs against UK GDPR and Data Protection Act
DPIA (Data Protection Impact Assessment) creation
Privacy Policy creation
Additional documents as needed (e.g. Legitimate Interest Assessment)
Combined with clinical safety, we can save time and money, and mitigate gaps.
NHS Product Rollout
Scalable DCB0160 support for your NHS customers, making you stand out from your competitors.
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NHS providers struggle to implement new technologies and meet DCB0160 and DPIA compliance requirements, and scrutiny is increasing.
Working between you and these customers, we can ease this process and deliver what most suppliers fail to provide, while keeping costs low.
Ongoing CSO and DPO support
Keep your product DCB and GDPR compliant through product updates and customer feedback.
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Named and accountable CSO or DPO for your product OR support for your in-house team
Incident Reviews and Annual Review
Major revisions of clinical safety case as needed due to product updates
Embedded CSO or DPO expertise into your tech team for compliance-informed product development (optional)
Fills expertise or bandwidth gaps in your team, on demand.
AI Education
Workshops and talks to upskill your team on the latest in clinical AI risks and opportunities
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Lunch and learns
Half day workshops
Delivered by experts in clinical, product and technology that speak your language.
For your technology, clinical or leadership teams
Our Clients
We partner with teams shaping the future of digital health and AI
Digital Health Companies
We work exclusively in digital health. We understand the safety and data risks unique to health technologies, and help you manage them so you can ship faster, safer, and with confidence.
Startups, SMEs, Enterprise
From first-time founders to established enterprises, we help teams cut through complexity, identify their biggest risks, and get to market fast.
Clinical AI PIoneers
We stay at the forefront of clinical AI: its opportunities and its risks. In a fast-moving space, we bring timely, on-demand expertise to keep your AI safe, compliant, and deployable.
Our team is unmatched in clinical safety and data protection for digital health and AI.
Decades of experience across healthcare delivery, technology, and product development.
Expert judgement you can trust: we make fast, right-sized, product-informed calls on risk for your customers and your business.
Shaping the future of clinical AI: we’re actively contributing to national frameworks with the Department for Business and Trade, the CQC, and Radiant Cersi.
