EU MDR / IVDR Compliance
Technical documentation, clinical evaluation, and conformity assessment — from classification to CE marking.
Where MDR/IVDR Gets Complex
The EU Medical Device Regulation demands more than documentation — it demands strategy.
Classification & Conformity
Determining the correct device class and conformity assessment route under the new regulation.
Technical Documentation
Building comprehensive technical files that meet Annex II/III requirements and satisfy notified bodies.
Clinical Evidence
Clinical evaluation reports, PMCF plans, and sufficient clinical data for your device class.
A Structured Path to CE Marking
Four focused phases that move you from regulatory ambiguity to a certified, market-ready device.
Regulatory Strategy & Gap Analysis
Device classification, conformity route selection, gap analysis against MDR/IVDR requirements.
Technical Documentation
Annex II/III compliant technical files — device description, risk management, clinical evaluation.
Clinical Evaluation & Evidence
CER/PMER preparation, literature review, clinical investigation planning if needed.
Notified Body Submission
Pre-submission meetings, document package preparation, response to questions.
End-to-End Regulatory Support
Every aspect of your MDR/IVDR compliance journey — handled with precision and regulatory depth.
Regulatory Intelligence
Track MDR/IVDR updates, MDCG guidance, and harmonized standards relevant to your device.
Technical File Management
Structured documentation with version control and cross-references across all Annexes.
Clinical Evaluation
Systematic literature review, equivalence assessment, and CER generation.
Risk Management
ISO 14971 compliant risk management throughout the product lifecycle.
Post-Market Surveillance
PMS plan, PSUR, vigilance reporting, and trend analysis.
UDI & EUDAMED
UDI assignment, EUDAMED registration, and economic operator obligations.
From Strategy to CE Marking
A realistic, phase-by-phase roadmap from initial strategy to successful certification.
Strategy & Gap Analysis
Device classification, gap assessment, regulatory roadmap .
Technical Documentation
Annex II/III files, CER, risk management, PMS plan .
Notified Body Review
Submission, Q&A responses, final document refinements .
CE Marking
CE certificate issued, EUDAMED registration, market release.
Start Your MDR / IVDR Certification
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