MDR compliance,
without the audit marathon
CertMD is an AI-native pre-audit platform that helps medical device companies prepare for EU MDR certification. Faster, with fewer consultants, and without the guesswork.
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 NB audit findings are avoidable with proper pre-audit 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
Running an ISO 13485 QMS audit
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 audit readiness in three steps
No setup, no integrations required. Upload what you have and CertMD does the work.
Securely upload or link your files
Upload your documents directly or connect files from your QMS system. Technical files, QMS procedures, risk management reports — any format, any state of completeness.
AI audit runs
CertMD maps your content against MDR Annexes, ISO 13485 clauses, and relevant ISO standards. Every finding is cited to the source regulation.
Get your gap report
Receive a structured, prioritised gap report with remediation guidance. Export NB-ready documentation packages directly from the platform.
The problem
EU MDR 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, ISO 13485, and all applicable ISO standards. It reasons over your documents, not generic prompts.
- Clause-level gap analysis against MDR Annexes
- ISO 13485 QMS pre-audit readiness check
- Grounded answers with cited regulatory sources
- Validated by EU Notified Body auditors
Product
Choose your audit track
Three focused pre-audit tracks. 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 Audit
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 Audit
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
FDA QMSR Transition
Your quality management system reviewed against FDA 21 CFR Part 820 (QMSR) requirements. Covers the transition from ISO 13485:2016 and identifies gaps in CAPA, design controls, supplier management, and complaint handling for US market access.
What you get
- QMSR clause-by-clause gap analysis
- ISO 13485 to QMSR transition roadmap
- CAPA and complaint handling readiness
- Remediation plan for each finding
Supporting tools
Documentation 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 guidance updates and NB interpretation changes.
In development MDCG · EUDAMEDEvidence Export
Export NB-ready documentation packages with full traceability. Every output is cited to the underlying regulatory source for your RA team to verify before submission.
In development Traceable · Auditor-readyTeam Workspace
Centralise your RA, QA, and R&D teams around a single compliance workspace. Assign tasks, track document status, and maintain audit trails automatically.
In development Multi-user · Audit trailCustom Workflow Integration
Don't want to use the web version? We integrate CertMD directly into your existing quality workflow — whether it’s your QMS platform, document management system, or a custom pipeline. Your process, our AI.
In development Custom · 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 pre-audit 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.