Clinical safety built for health tech.
One platform for your DCB0129 work and your customers' DCB0160 compliance. Features, changes, hazard logs: designed for how modern health tech teams actually build software.
Patient messaging v2.1
Released • 3 hazards controlled
AI appointment triage
In development • 2 hazards pending
Lab results integration
Planned • 0 hazards identified
A platform built for how you actually work
Clinical safety shouldn't live in spreadsheets. Protect Clinical is designed for modern health tech teams, with features that fit your development workflow.
Features
Organise hazards by feature, including features you haven't released yet. Build your safety case as you build your product.
Proactive safety, not reactive paperwork
Changes
Track changes as they happen. Assess risk impact, document mitigations, and maintain an audit trail without the overhead.
Change control that doesn't slow you down
Jira Integration
Link hazards to Jira tickets. Clinical safety becomes part of your workflow, not a separate process.
Coming soonHazard Logs
AI-assisted hazard identification. Risk matrices that make sense. Export-ready for audits and regulatory submissions.
Safety Cases
Structured safety arguments with evidence linkage. Generate professional documentation that satisfies DCB0129 requirements.
Clinical Safety Management System
Your CSMS, documented and maintained. Roles, processes, incident management. All in one place.
One platform. Both standards. Complete visibility.
Use Protect Clinical for your DCB0129 compliance and offer it to your customers for their DCB0160 work. Same platform, unified safety thinking, and you'll understand exactly how your customers think about clinical safety.
Give your customers a real answer
Protect Clinical helps your deployers achieve DCB0160 compliance, so you can focus on building great software.
Recommend to your customers
Point customers to Protect Clinical when they ask about DCB0160. They get proper support; you reduce your support burden.
- Clear answer to customer questions
- Reduces support ticket volume
- Shows you take clinical safety seriously
Product-specific templates
We can work with you to create hazard log and safety case templates pre-configured for your product, giving your customers a head start.
- Pre-populated with common hazards
- Aligned with your DCB0129 safety case
- Faster time-to-compliance for deployers
White-label partnership
Offer Protect Clinical as part of your product package. Your customers get clinical safety support; you differentiate from competitors.
- Competitive differentiator
- Customer success enabler
- Revenue share available
CSO consultancy for your team
Need CSO support for your own DCB0129 work, SaMD compliance, or QMS? Charlotte has 7+ years in health tech and can help.
- DCB0129 safety case support
- ISO 14971 / QMS 13485 experience
- Audit preparation
We speak health tech.
Our Clinical Safety Officer, Charlotte Caws, brings years of health tech experience. She understands the challenges of building and deploying clinical software.
With experience across DCB0129/0160, ISO 14971 (Software as Medical Device), and QMS 13485, she can support your compliance needs at every level.
Charlotte Caws
Clinical Safety Officer
"I've worked on both sides, clinical and tech. I understand the pressure vendors face to ship, and the real-world consequences when clinical safety isn't done right. That's why I focus on practical, proportionate approaches."
Let's explore a partnership.
Whether you want to recommend us to customers, create product-specific templates, or discuss white-labelling—we'd love to talk.