AI-Powered Unified
End-to-End MedTech Compliance Platform
Compliance checks in minutes, manage workflows, and access on-demand experts, all in one platform. Across EU MDR, IVDR, ISO 13485, and 100+ ISO/IEC standards, from SaMD to implants.
Validated by EU Notified Body auditors
Annex IX: Technical Documentation
Risk management file (ISO 14971)
MDR Article 61: Clinical Evaluation
Post-market clinical follow-up plan
ISO 13485:2016: QMS Clause 7.3
Design & development controls
3–5×
faster time-to-technical documentation vs. traditional consultancy
40%
of Notified Body audit findings are avoidable with proper compliance preparation
76%
of manufacturers report significant documentation bottlenecks before submission
Who it's for
Built for the people who own compliance
CertMD is designed around the real workflows of RA and QA professionals. Not generic document tools.
RA Manager · SME Medtech
Preparing a first NB submission
You're 6–12 months from your first MDR submission and need to close Technical Documentation gaps without hiring another consultant.
Freelance Regulatory Consultant
Managing multiple device clients
You run parallel MDR projects across several manufacturers. CertMD acts as your always-on RA assistant: clause lookups, gap reports, and documentation in minutes.
QA Lead · Class I–IIb Device
Certifying an ISO 13485 QMS
Your QMS needs to be audit-ready for ISO 13485. CertMD maps your existing procedures against every relevant clause and surfaces gaps before your auditor does.
How it works
From documents to compliance readiness in three steps
No setup required to start. Upload what you have and CertMD does the work, with deeper system integrations on the way.
Securely upload or link your files
Upload your documents directly or connect files from your QMS system. Technical files, QMS procedures, risk reports, performance evaluations, any format, any state of completeness.
AI compliance review runs
CertMD maps your content against EU MDR, IVDR, ISO 13485 clauses, and 100+ ISO/IEC standards, with cross-document traceability and consistency checks included. Every finding is cited to the source regulation.
Get your gap report
Receive a structured, prioritised gap report with remediation guidance in a unified dashboard. Then scale it with workflow tools or on-demand expert support from auditors, consultants, CROs, and test houses.
The problem
MedTech compliance is expensive, opaque, and slow
The regulation came into full effect in 2024 and most SMEs are still not ready. Legacy consultancy models were not built for it.
Knowledge is siloed and inaccessible
MDR and ISO 13485 requirements span hundreds of clauses with shifting NB interpretations. No single source of truth exists.
Consultants are expensive and hard to scale
RA consultants bill €200 to €400/hr. A full MDR tech file review takes months and costs six figures for a single device.
Gaps surface at the worst possible moment
Compliance gaps are discovered during NB audits, not before. Rectification under scrutiny multiplies cost and delay significantly.
CertMD gives your team an always-on compliance co-pilot
Our AI is grounded in a continuously updated, auditor-annotated knowledge base covering EU MDR, IVDR, ISO 13485, and 100+ ISO/IEC standards for device types from SaMD to implants to disposables. It reasons over your documents, not generic prompts.
- Clause-level gap analysis against EU MDR, IVDR & ISO 13485
- Cross-document traceability & consistency checks
- Unified dashboard, workflow tools & evidence exports
- On-demand expert support from auditors, CROs & test houses
- Continuous compliance & full system integration, coming soon
Product
Choose your compliance track
Four focused tracks across EU MDR, IVDR, ISO 13485, and 100+ ISO/IEC technical standards. Each one runs a full compliance pass on your documents and hands you a structured report your team can act on immediately.
Track A
Technical Documentation Review
Your full technical file, reviewed against MDR Annex II/III, GSPR, and your Clinical Evaluation Report. ISO 14971, IEC 62304, and other applicable ISOs are covered within the TD review wherever they appear in your documentation.
What you get
- Applicable clauses mapped to your content
- Missing documentation identified and prioritised
- Non-conformities flagged with regulatory citations
- Remediation recommendations, ready to act on
Track B
ISO 13485 QMS Review
Your quality management system, reviewed clause by clause against ISO 13485:2016. This covers your SOPs, processes, and quality procedures at the QMS level, including whether the right processes for risk management and design control are in place.
What you get
- Applicable clauses mapped to your QMS
- Missing procedures and process gaps identified
- Non-conformities flagged with clause references
- Remediation recommendations for each finding
Track C
IVDR Technical Documentation
Your IVDR technical documentation reviewed against Annex II/III, GSPR, and applicable standards for in-vitro diagnostics, from simple kits to high-risk companion diagnostics, including SaMD and software components.
What you get
- Applicable clauses mapped to your IVD file
- Missing performance and clinical evidence identified
- GSPR and standard gaps flagged with citations
- Remediation recommendations, ready to act on
Track D
Deep Technical Standards Review
Beyond the regulation itself, a deep technical dive against 100+ ISO/IEC standards applied by your Notified Body, covering a broad range of device types from SaMD and active devices to implants and disposables. Every applicable standard is checked clause by clause against your engineering and design data, so device-specific technical compliance is assessed, not just the MDR framework. This is the same scrutiny as a specialist assessor, but weeks earlier.
What you get
- Full map of the standards that apply to your device class
- Device-type-specific checklists from SaMD to implants to disposables
- Engineering and design data gaps flagged with citations
- Prioritised remediation and expert escalation paths
Supporting tools
On-Demand Expert Support
Tap a network of regulatory auditors, consultants, CROs, and test houses to review AI findings and close gaps faster, without hiring an in-house team.
Auditors · Consultants · CROs · Test housesTraceability & Consistency
Cross-document checks that verify every requirement is traced to evidence and that content stays consistent across your technical file, QMS, and risk documentation.
Cross-document · Always onDocumentation Co-pilot
Generate compliant technical file sections, QMS procedures, and risk management content grounded in your device's specific classification and intended purpose.
In development Drafting · TemplatesRegulatory Intelligence
Ask plain-language questions and get answers cited to the underlying regulation. Stay current with MDCG and NB interpretation changes.
In development MDCG · EUDAMEDUnified Dashboard & Workflow
Track every audit, finding, and remediation task in one dashboard. Assign work across RA, QA, and R&D teams and export auditor-ready evidence packages.
Insights · Workflows · Audit trailContinuous Compliance & Integration
Full integration into your QMS and systems, with continuous compliance triggered by any change, so you're always audit-ready. Coming soon.
Coming soon API · QMS integrationData & Security
Your data is yours. Always.
Medical device documentation is some of the most sensitive IP your company holds. We treat it that way.
Never used to train AI models
Your documents are never used to train or fine-tune any AI model. What you upload stays yours, full stop.
Encrypted in transit and at rest
All data is encrypted with TLS 1.3 in transit and AES-256 at rest. Infrastructure runs on Google Cloud Platform (EU region).
ISO 27001 controls in place
We have implemented ISO 27001-aligned information security controls. Formal certification is in progress. Our security posture is available on request.
Ready for trial with your documents
Book a demo and run CertMD against a sample of your actual technical file. See exactly what a compliance review looks like before committing to anything.
GDPR compliant
We comply with the EU General Data Protection Regulation. You have the right to access, correct, delete, or port your data at any time by contacting us.
EU-hosted infrastructure
All data is processed and stored exclusively in Google Cloud Platform's EU region (europe-west4). No data leaves the European Economic Area.
FAQ
Common questions
Everything you need to know before booking a demo.
Get started
See CertMD on your documents
30 minutes. We'll run a live compliance pass on a sample of your technical file and show you exactly where the gaps are, across EU MDR, IVDR, ISO 13485, and the standards that apply to your devices.
Book a demoNo commitment. Available in English and German.