Regulatory & Quality
ISO 13485-Certified Quality Management
RESOLTIVE operates under a comprehensive quality management system certified to ISO 13485:2016, covering all R&D and engineering activities at the Montpellier site. Every process, from design control and risk management to document control and post-market surveillance, is implemented in compliance with international IVD regulatory requirements.
The facility holds FDA registration as a contract manufacturer in accordance with QSR 21 CFR Part 820, enabling our OEM clients to access both European and US markets with confidence and rely on RESOLTIVE’s regulatory documentation as part of their own submissions.
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Regulatory Documentation
Production of complete technical files, design history files and risk management reports supporting CE IVD marking and FDA 510(k) submissions on behalf of our OEM partners.
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Design Verification & Validation
Structured V&V protocols executed under GMP conditions, generating the objective evidence needed to demonstrate conformity with applicable IVD performance and safety standards.
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Post-Market Surveillance
Ongoing monitoring of field performance data, customer complaints and vigilance reporting to maintain regulatory compliance throughout the full product lifecycle.
Supporting Global Market Access
RESOLTIVE’s regulatory expertise spans the European CE IVD framework, FDA requirements for the US market, and major international markets, ensuring that instruments developed in Montpellier can be cleared for worldwide distribution. Our quality and regulatory team collaborates closely with OEM partners’ own regulatory affairs functions, providing the technical evidence and documentation needed for efficient approvals.
- ISO 13485:2016 and FDA QSR-compliant quality management system
- CE IVD and FDA 510(k) regulatory filing and documentation support
- Risk management per ISO 14971 and IEC 62366 usability engineering