Managing Ongoing Compliance
Medical device regulatory compliance is not a one-time achievement but an ongoing responsibility. Design modifications, manufacturing changes, and evolving regulatory requirements all create obligations to update documentation and notify regulators.
RegOps provides lifecycle management services that maintain your regulatory standing throughout your device's commercial life. We help you assess change significance, determine regulatory pathway implications, update technical documentation, and execute necessary submissions. Our lifecycle approach ensures that your regulatory investments are protected and your devices remain available to the patients and clinicians who depend on them.
Our Capabilities
Systematic change management and lifecycle support.
Systematic evaluation of changes to determine regulatory significance under FDA, MDR/IVDR, and other frameworks. We classify changes and identify required notifications or submissions.
Application of FDA guidance to determine when device modifications require new 510(k) submissions. We help you establish procedures and document modification decisions defensibly.
Ongoing maintenance of technical files and Design History Files to reflect accumulated changes. We ensure documentation remains current and ready for inspection.
Preparation of change notifications, supplements, and amendments including FDA modifications and EU significant changes updates to maintain market authorizations.
Management of CE certificate renewals, FDA establishment registrations, and device listings. We track deadlines and ensure timely compliance to maintain market access.
Regulatory planning for product discontinuation including notification requirements and documentation retention. We help you exit markets compliantly.
The RegOps Advantage
We establish procedures that enable consistent change evaluation and regulatory decision-making across your portfolio.
Systematic Approach
We establish procedures and tools that enable consistent change evaluation and regulatory decision-making.
Regulatory Currency
We maintain awareness of evolving regulatory expectations, ensuring your change assessments reflect current agency positions.
Documentation Discipline
We prioritize documentation practices that create clear audit trails, supporting regulatory inspections and compliance.
Portfolio Perspective
We coordinate lifecycle activities across products to ensure consistency and optimize regulatory resources.