REGULATORY COMPLIANCE
The EU Medical Device Regulation (MDR) 2017/745 has significantly increased regulatory requirements for medical device manufacturers. Navigating MDR compliance requires structured planning, accurate documentation, and a clear understanding of regulatory expectations.
We support manufacturers in meeting MDR requirements efficiently while maintaining compliance throughout the device lifecycle.
Comprehensive evaluation of your current regulatory position against MDR requirements, identifying gaps and providing actionable remediation plans.
Development of complete technical documentation packages meeting MDR Annex II and Annex III requirements, structured for notified body review.
Expert review of existing technical documentation to ensure regulatory completeness, accuracy, and compliance with MDR standards.
Determination of device classification under MDR rules, development of regulatory pathways, and strategic planning for conformity assessment.
Preparation for notified body audits and assessments, including documentation review, gap remediation, and readiness evaluation.
Implementation of post-market surveillance systems, periodic safety update report (PSUR) development, and vigilance support.
Continuous regulatory support throughout the device lifecycle, ensuring sustained compliance with evolving MDR requirements.
Our consultancy is designed to reduce uncertainty and help manufacturers move forward with confidence.
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