At IDE, Regulatory Affairs isn’t merely about regulatory compliance.

It’s about navigating the complex landscape of medical device regulatory requirements through an entrepreneurial lens.

How we do it

We understand that regulatory strategy is business strategy for medical devices. That’s why we offer tailored solutions that address your specific regulatory needs, whether it’s working with a notified body, establishing an authorised representative, or ensuring adherence to new and changing global regulations, all while keeping your business objectives front of mind.

Our team has extensive experience navigating regulatory requirements across multiple jurisdictions. With experience navigating regulatory requirements in over 90 countries, including the United States and European Union, we help you understand the nuances of local regulations and guide you through the complexities of international markets.

From initial concepts to post-market expansion and scaling, we provide guidance across all aspects of regulatory affairs to ensure that your medical devices meet the highest standards of safety and efficacy throughout the entire lifecycle of the product.

We work closely with regulators, suppliers, and strategic business partners to streamline the regulatory process and expedite product approvals. Our strategic partnerships ensure that your medical devices comply with all applicable regulations, allowing you to bring them to market faster.

We know that keeping up with changes to medical device regulations globally is a daunting task. We monitor the latest regulatory developments and changes, providing you with the regulatory intelligence you need to make informed decisions and stay ahead of the curve.

What sets us apart

  • Integration with Product Development: We seamlessly integrate regulatory considerations into every stage of product development, ensuring that regulatory compliance is built into the fabric of your medical devices from the outset and setting you up for success as your venture grows.

  • Turnkey Solutions: IDE serves as a one-stop-shop for all your regulatory needs, providing comprehensive services that cover everything from initial strategy development to submission for marketing approval and beyond.

  • Facilitated Communication: Whether you’re communicating directly with regulators, or you have internal regulatory experts and are looking for a little extra support, we act as facilitators, ensuring smooth communication and collaboration throughout the product development and submission process.

We recognise that regulatory strategy is essential for the commercial success of your medtech venture. That’s why we provide customised solutions to ensure compliance with evolving global regulations while keeping your business objectives at the forefront of our approach.

We’re committed to helping you navigate the complex world of medical device regulatory affairs with confidence and ease.

Let us be your partner in achieving regulatory compliance and bringing safe and effective medical devices to market.