Cap Compliance

France

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Cap Compliance is a French regulatory and compliance consulting firm located in Sophia Antipolis (Valbonne). The firm specializes exclusively in the medical device and in vitro diagnostic (IVD) sectors, assisting manufacturers, start-ups, and subcontractors with regulatory strategies and certification processes.

The company provides targeted consulting on design control (maîtrise de conception), risk management, and the compilation of audit-proof technical documentation to secure CE marking under the EU Medical Device Regulation (MDR 2017/745) and IVDR (2017/746), as well as compliance with FDA eQSR requirements and ISO 13485.

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Cap Compliance assists medical technology companies with structured design-stage compliance and regulatory approval:

Design Control & Technical Documentation: Establishing design controls compliant with ISO 13485 and MDR Annex II/III, drafting Design History Files (DHF) and Device Master Records (DMR), and managing design reviews and milestones.
CE Marking Dossiers (MDR & IVDR): Drafting, gap analysis, and defense of Technical Files before European Notified Bodies, ensuring alignment with General Safety and Performance Requirements (GSPR).
Risk Management & Usability: Structuring risk management files according to ISO 14971, integrating benefit-risk ratios, and creating usability engineering files compliant with IEC/EN 62366-1.
Biocompatibility Assessment: Biological safety evaluation plans and reports aligned with the ISO 10993 series and MDR Annex I (§10) expectations.
Quality Management Systems (QMS): Setup, gap analysis, and internal audits for ISO 13485, MDSAP programs, and FDA QMSR compliance.

Cap Compliance

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