Regulatory Compliance
We have experience navigating medical regulatory frameworks, including the preparation and support of FDA 510(k) submissions as well as compliance with the European Medical Device Directive (MDD) and the latest Medical Device Regulation (MDR). Our expertise ensures that hardware and software developments are designed, documented, and validated to meet strict regulatory requirements, enabling clients to bring safe, effective, and compliant medical technologies to market with confidence.
Expert advice to navigate engineering challenges effectively.