Our Regulatory Services provide end-to-end support to ensure your medical devices meet the latest global requirements for safety, performance, and compliance. We specialise in helping companies prepare, maintain, and optimise the technical and risk documentation required by regulators and notified bodies.
Technical Documentation (MDR/IVDR & International Standards):
Preparation, review, and gap analysis of technical files for compliance with EU MDR, IVDR, and other global regulations.
Support in compiling essential requirements checklists, device descriptions, intended use statements, and design dossiers.
Clinical evaluation report (CER) and performance evaluation report (PER) review and guidance.
Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) documentation support.
Assistance with labelling, instructions for use, and conformity assessment documentation.
Risk Management (ISO 14971):
Implementation and review of risk management processes in line with ISO 14971 and latest guidance.
Development of risk management plans, risk analysis, risk evaluation, and risk control strategies.
Creation and maintenance of risk management files, ensuring traceability from hazard identification through to residual risk evaluation and benefit-risk analysis.
Integration of risk management activities throughout the device lifecycle, including production and post-production monitoring and feedback.
Guidance on aligning risk management documentation with quality management system (QMS) and technical documentation requirements12.
Why Choose Qualisure for Regulatory Services?
Deep experience in preparing and remediating technical documentation for EU, UK, and global markets.
Proven track record in risk management system implementation and audit readiness.
Up-to-date knowledge of evolving regulatory expectations and best practices.
Practical, actionable recommendations to streamline documentation and reduce regulatory delays.
Let us help you build robust, audit-ready technical and risk documentation that supports successful submissions, market access, and ongoing compliance.