Don't let DCB0160 stall your sales.
Practices discover they need a DCB0160 assessment before deploying your product. Most don't know where to start. Deals slow down. Protect Clinical turns your DCB0129 into a deployment-ready compliance template your customers can sign off in hours, not weeks.
Patient messaging v2.1
Released • 3 hazards controlled
AI appointment triage
In development • 2 hazards pending
Lab results integration
Planned • 0 hazards identified
Manage your own DCB0129 on the same platform
Clinical safety shouldn't live in spreadsheets. Protect Clinical is designed for modern health tech teams — organise hazards by feature, track changes as you ship, and maintain an audit-ready safety case.
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.
Your DCB0129 becomes their DCB0160.
We take your existing DCB0129 documentation and convert it into a DCB0160 deployment template on Protect Clinical. When a practice deploys your product, they get a pre-populated compliance framework written from the deploying organisation's perspective — hazards, controls, and mitigations ready to review rather than build from scratch. Your sales conversation changes from “DCB0160 is your responsibility” to “we've helped you take care of that.”
Remove the compliance barrier from your sales process
When practices discover they need DCB0160 compliance to deploy your product, the deal stalls. Protect Clinical gives them a clear path forward so you can close faster.
Recommend to your customers
When a practice asks "what about DCB0160?", point them to Protect Clinical. They get expert guidance; you keep the deal moving.
- Unblock stalled deployments
- Reduces your support burden
- Shows you take clinical safety seriously
Bundle compliance with your product
We convert your DCB0129 into a DCB0160 deployment template. Practices log in, review with CSO guidance, and sign off. Hours of practice time, not weeks.
- Pre-populated from your DCB0129 safety case
- Written from the deploying organisation perspective
- Template updates when your product changes
White-label partnership
Offer Protect Clinical as part of your product package. Your customers see one price for your product plus compliance. No separate procurement process.
- Removes DCB0160 as a buying objection
- Competitive differentiator
- 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."
Stop losing deals to DCB0160.
Tell us about your product and your customers. We'll show you how to bundle compliance and close faster.