Regulatory Services
Expert EU MDR & IVDR Regulatory Services for Medical Devices
Your Strategic Partner for Navigating European Regulatory Complexity and Accelerating Your Path to Market.
Successfully launching and maintaining a medical device in the European Union is more than an innovation challenge—it's a regulatory marathon. The stringent requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are the cornerstone of market access, demanding deep expertise and meticulous attention to detail. At Aequum, we provide comprehensive, end-to-end regulatory services designed to transform compliance from a hurdle into a strategic advantage.
Our dedicated team of regulatory specialists offers tailored solutions that guide you through every stage of the product lifecycle. From early-stage strategy development to ongoing post-market surveillance, we ensure your products not only meet but exceed the rigorous standards of the EU. We act as a seamless extension of your team, making the complex simple.
Our Key Regulatory Services Include:
EU MDR & IVDR Compliance Strategy We provide a clear and actionable roadmap for your device's journey to compliance. Our strategic services include product classification, defining the most efficient regulatory pathway, and developing a comprehensive plan that aligns with your commercial goals, ensuring you start your project with a solid foundation for success.
Technical File Preparation & Review The Technical File is the bedrock of your CE marking. We assist in compiling, structuring, and reviewing all necessary technical documentation, clinical evaluations, and risk management plans. Our expert oversight ensures your submission is robust, complete, and ready for notified body scrutiny.
Expert Notified Body Coordination Effective communication with notified bodies is critical to avoiding unnecessary delays. We manage the entire submission and review process, acting as your professional liaison with EU authorities. Our experience ensures that communication is clear, efficient, and geared towards a successful and timely market approval.
Post-Market Surveillance & Risk Management Compliance does not end at launch. We help you establish and maintain proactive post-market surveillance (PMS) and risk management systems. This ensures you meet your ongoing obligations, maintain product safety, and gather valuable data for future product improvements, safeguarding your market presence for the long term.
Let Aequum be your trusted regulatory partner in Europe. We handle the complexity of compliance so you can focus on what you do best—innovation.