01
Clarity first
Know what matters before the work begins.
Agentic AI for MedTech quality & innovation
Accelerate healthcare
innovation & quality.
Success in Medtech can be an uphill battle. Compliance is often opaque. Providers and suppliers are typically disconnected. Qyro delivers a connected living system that helps you build and scale safely.
Built forMedical Devices · Clinical Safety · Product Teams · Operational Excellence
How Qyro works
Success simplified.
We combine an agentic AI platform with specialist leadership so you can understand what's required, build the right system and keep it working as you ship and scale.
SpansDiscover · Build · Operate
01Step
Understand your landscape
Qyro onboards your organisation, products and deployments, mapping them to the relevant standards and obligations for suppliers and providers.
02Step
Build a living quality system
Generate, tailor and manage a structured library of documents, hazards and training, all mapped clause-by-clause to the standards that matter.
03Step
Operate with continuous assurance
Keep your posture current as you ship, iterate and scale. Qyro tracks evidence, changes and reviews so audits feel calm, predictable and organic.
Inside the Qyro workspace
From burden to momentum.
Qyro turns regulatory complexity into a living quality system, helping HealthTech teams move from uncertainty to safer products, stronger trust and better commercial readiness.
OnboardingDocumentsEvidenceTrainingInsights
02
Living artefacts
Turn quality work into tools your team can actually use.
03
Proof in motion
Evidence builds naturally as the work happens.
04
Intelligence built in
AI helps translate content into action and training.
05
Confidence at a glance
See progress, readiness and quality posture in one place.
How we can support
End-to-end support for MedTech innovators.
Combine Qyro's agentic AI platform with specialist advisory and leadership services. Whether you're a supplier deploying into health systems or a provider assuring complex supplier landscapes, we help you successfully navigate product development, operations and strategy while focusing on quality.
Product · Quality · Regulatory · IG
Fractional leadership
- Access to quality senior leadership
- Embed governance that scales
- Support exec, board and investor reporting
Platform + servicesSuppliers & providers
ISO 13485 · DCB0129 · DCB0129
Quality & regulatory advisory
- Design and refine ISO 13485–ready QMS
- Build clinical safety files and evidence packs
- Prepare for audits and customer due diligence
Platform + servicesSuppliers & providers
DCB0129 · DCB0160 · ISO 13485
Clinical Safety Officer (CSO)
- Clinical risk management and hazard logs
- Safety cases, sign-off and ongoing governance
- Aligned to local and national safety processes
Platform + servicesSuppliers & providers
GDPR · DSPT · DTAC
Data Protection Officer (DPO)
- Independent oversight of GDPR compliance
- DPIAs and data sharing aligned to the NHS
- Building DSPT, DTAC and customer trust
Platform + servicesSuppliers & providers
Security · Performance
Technology assurance
- Penetration and security testing of your stack
- Load and performance testing of key workflows
- Technical due diligence for major deployments
Platform + servicesSuppliers & providers
Standards we help you meet
For suppliers
ISO 13485
ISO 14971
DCB0129
CQC
DTAC
DSPT
GDPR
Cyber Essentials
ISO 27001
For providers
DCB0160
CQC
Supplier conformance
GDPR
Information security
Qyro supports you across the full lifecycle — from first deployment through change control to ongoing assurance against these standards.
Product & service tiers
Right-sized support for where you are now.
Each tier combines the Qyro platform with advisory and leadership support. We shape the engagement around your products, markets and regulatory obligations.
Foundation
For teams taking their first structured step into quality and compliance.
Get organised quickly with core workflows, essential documents and guided setup.
Growth
For organisations expanding products, customers or markets.
Add automation, portfolio views and coverage across multiple standards and stakeholders.
Scale
For complex portfolios and health-system scale deployments.
Support multi-entity governance, deeper assurance and leadership engagement.
Platform and service bundles are shaped around your products, markets and regulatory obligations.
Get pricingWhy teams choose Qyro
Tools designed to drive quality.
Qyro brings together agentic regulatory intelligence, execution tooling and specialist leadership — enabling MedTech teams to move faster without compromising safety or assurance.
How Qyro feels in use
One space to understand, act and stay ahead.
From the first document to portfolio-level oversight, Qyro shows teams exactly what’s needed and what happens next — keeping quality predictable and calm.
1
Agentic regulatory intelligence
Qyro interprets ISO and other major standards and frameworks in context — tailoring requirements to your product, evidence and lifecycle. Not generic checklists or templates.
2
Total lifecycle visibility
One connected view across strategy, hazards, risks, evidence, documents and releases — enabling leadership to see compliance posture instantly and focus investment where it matters.
3
Execution built in
AI-generated documents, flowcharts, logs and checklists; guided approvals, training, and versioning. Everything teams need to embed quality and ship safely — not just assess it.
4
Continuous assurance
Qyro actively monitors change, risk and evidence across your portfolio. Real-time insight replaces point-in-time audits, lowering the cost and burden of compliance.
5
Amplified by expert leadership
Clinical safety officers, regulatory advisors, fractional leaders and technical assurance services combine with the platform to provide end-to-end confidence, not just software.
6
Regulator-ready from day one
Built for the scrutiny of notified bodies, NHS assurance teams and clinical safety officers — with verifiable audit trails, controlled evidence chains and rapid, low-friction deployment.
The Qyro philosophy
Health. Forward.
We work with ambitious HealthTech teams building what comes next, helping turn strong ideas into trusted products, safer systems, and better outcomes.
Health
Help innovators improve lives.
We partner with visionary founders, operators, clinicians and HealthTech teams who want to build tools that make a real difference, whether that means better access, clearer decisions, safer services or stronger outcomes.
For us, quality is not a layer added at the end. It is part of how good healthcare technology earns trust, continuously innovates and becomes increasingly useful in the real world.
Forward
Deliver high quality innovation.
Healthcare is being reshaped by software, AI and evolving standards. We believe progress matters most when it is responsible, credible and ready to stand up to scrutiny.
Qyro helps teams move forward with the structures that make innovation stick, from governance and evidence to quality systems that evolve with the technology itself.
Resources
Field notes from regulated healthcare innovation.
Practical case studies, reflections and lessons from the work of building trusted MedTech and AI products, quality systems and commercially credible operations.
See Qyro in action
Watch the platform bring your quality system to life.
In a live walkthrough we'll show how Qyro turns standards into a living system – generating tailored documents, surfacing risks and embedding training, all in a single, calm workspace.
Book a live demoTypically 30–45 minutes. Let's talk about your current challenges.
Documents & evidence
See how Qyro builds and maintains your tailored document library and audit trail.
Risks & hazards
Explore risk logs, clinical safety and IG posture in one aligned view.
Training & culture
Walk through targeted training and how teams evidence understanding.
Qyro platform
Documents · Risks · Training
Docs & evidence
Risks & hazards
Training & culture