The Foundation of Compliance
The technical file (or technical documentation under MDR/IVDR) is the foundational regulatory document for medical devices marketed in the European Union and many other jurisdictions.
RegOps develops technical files that meet current regulatory expectations and support efficient Notified Body review. We structure documentation logically, ensure traceability between requirements and evidence, and present information at appropriate depth for device complexity. Our technical files serve not just as regulatory submissions but as living documents that support ongoing compliance throughout your device's lifecycle.
Our Capabilities
Comprehensive technical documentation services.
Comprehensive documentation of device design, intended purpose, indications for use, user profiles, and use environments. We establish clear device identity scope that anchors all documentation.
Systematic mapping of General Safety and Performance Requirements (MDR Annex I) to supporting evidence. We ensure every applicable requirement is addressed with traceable verification.
Complete documentation of design inputs, outputs, verification, validation, and manufacturing processes. We present design history appropriate to device classification and risk.
ISO 14971-compliant risk management files including hazard identification, risk estimation, control measures, and residual risk evaluation supporting benefit-risk determination.
Biological safety evaluation following ISO 10993, including material characterization, toxicological assessment, and testing rationale proportionate to patient contact.
Comprehensive clinical evaluation (CER) following MEDDEV 2.7/1 Rev 4 or MDR requirements. We develop CERs that satisfy Notified Body scrutiny and support benefit-risk conclusions.
The RegOps Advantage
We avoid approaches based on outdated MDD-era practices, ensuring alignment with current Notified Body expectations.
Regulatory Alignment
We develop documentation aligned with current MDR/IVDR requirements, MDCG guidance, and Notified Body expectations.
Scalable Approach
Our documentation depth scales with device classification. We avoid under-documentation issues and over-documentation waste.
Lifecycle Foundation
We structure files to support ongoing maintenance, design changes, and post-market updates beyond initial certification.
Cross-Jurisdictional
We develop documentation that supports multiple regulatory submissions, maximizing value across target markets.