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Compliance audits 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
Designed around the real workflows of RA and QA professionals, not generic document tools.
RA Manager · SME MedTech
Close technical documentation gaps without adding another consultant to the bill.
Regulatory Consultant
An always-on RA assistant for clause lookups, gap reports and documentation.
QA Lead · Class I to IIb
Map your procedures against every clause and surface gaps before your auditor does.
No setup required. Upload what you have and CertMD does the work.
Technical files, QMS procedures, risk reports, performance evaluations. Any format, any state of completeness.
Mapped against EU MDR, IVDR, ISO 13485 and 100+ ISO/IEC standards, with cross-document traceability and consistency checks.
Every requirement is traced to its supporting evidence, and cross-document inconsistencies are surfaced in a single map.
A structured, prioritised report with remediation guidance. Every finding cited to the source regulation.
Devices must be designed and manufactured to minimise risks from materials, including corrosion, wear debris and nickel release, with reference to ISO 10993-1.
The Biocompatibility Assessment (Rev 3) cites ISO 10993-1 but no corrosion or wear-debris report for the Ti-6Al-4V ELI implant. Hazard H5 (allergic reaction) is listed in the risk file but not linked to a test result.
Add the corrosion / wear-debris report (ISO 10993-15, ASTM F1877) and link it to H5. Update the Clinical Evaluation Report to reference the new evidence.
MDR came into full effect in 2024 and most SMEs are still not ready. Legacy consultancy models weren't built for it.
Hundreds of clauses with shifting NB interpretations, and no single source of truth.
RA consultants bill €200 to €400 per hour. A full technical file review takes months and costs six figures.
Found during the NB audit, not before, where rectification multiplies cost and delay.
Grounded in a continuously updated, auditor-annotated knowledge base across EU MDR, IVDR, ISO 13485 and 100+ ISO/IEC standards, from SaMD to implants to disposables. It reasons over your documents, not generic prompts.
Four focused audits across EU MDR, IVDR, ISO 13485 and 100+ ISO/IEC technical standards. Run one, or run them all, on the same documents.
Technical documentation
Your full technical file reviewed against MDR Annex II/III and the general safety and performance requirements, with applicable ISO and IEC standards covered wherever they appear.
Quality management
Your quality management system reviewed clause by clause against ISO 13485:2016: SOPs, processes and quality procedures at the QMS level.
In-vitro diagnostics
IVDR documentation reviewed against Annex II/III and GSPR for in-vitro diagnostics, from simple kits to high-risk companion diagnostics.
Technical standards
A deep dive against the 100+ ISO/IEC standards applied by your Notified Body. Engineering and design data checked clause by clause, from SaMD to implants.
Real outcomes from MedTech teams using CertMD across EU MDR, IVDR and ISO 13485.
An orthopaedic implant maker moving from MDD to MDR. CertMD reviewed the legacy technical file against MDR Annex II/III and the GSPRs, surfacing documentation gaps and cross-document inconsistencies in design controls, the risk file and the clinical evaluation, with a prioritised remediation list.
140+ gaps & inconsistencies foundA European implant company launching a new MDR Class II product. CertMD ran full-file technical and quality audits so the team could focus on the decisions instead of document wrangling.
60% less compliance effortA large MedTech building diagnostic hardware and software in the UK, going for Class IIa certification. CertMD audited the technical documentation against EU MDR and the applicable IEC standards.
Start with a trial on your own documents, then scale to full-file audits. We scope every engagement to your device and document volume.
Trial
Every CertMD feature for one month, so you can run real audits on your own documents.
Full use
The same full platform on an annual plan, for ongoing compliance across your devices.
The only difference is duration: one month on the trial, twelve months for full use. Get in touch and we'll set you up.
Medical device documentation is some of the most sensitive IP you hold. We treat it that way.
Your documents are never used to train or fine-tune any AI model. What you upload stays yours.
TLS 1.3 in transit and AES-256 at rest, running on Google Cloud Platform in the EU region.
All data is processed and stored exclusively in Google Cloud's europe-west4 region. Nothing leaves the EEA.
ISO 27001-aligned information security controls, with least-privilege IAM and full audit logging. Certification in progress.
Full EU GDPR compliance. Access, correct, delete or port your data at any time.
Book a demo and run CertMD against a sample of your actual technical file, before committing to anything.
Everything you need to know before booking a demo.
30 minutes. We'll run a live compliance pass on a sample of your technical file and show you exactly where the gaps are.
No commitment · Available in English and German
Send us a message and we'll get back to you. Prefer a call? Use "Book a demo" above.
Email: info@certmd.com