We offer

We offer end-to-end leadership and guidance for EU MDR and FDA regulatory and quality compliance for medical software. Our services cover the entire process, from device classification to compiling regulatory submissions, providing comprehensive solutions to ensure your success.

We conduct analysis to identify gaps in complying with applicable regulations, guidances, and international standards. Our comprehensive approach to compliance analysis ensures you are implementing the correct standards for your business and products. With our help, you will meet all the necessary requirements and stay ahead of the curve.

We will help you navigate the complex landscape of regulatory compliance and implement a Quality Management System (QMS) that meets all the necessary requirements for your specific market and device type. With our help, you will be able to implement a QMS that is lightweight and optimized for designing and developing medical software.

We will guide you through the entire regulatory submission process, develop your regulatory strategy, compile your 510(k) and/or technical documentation and help you submit your application for approval. During the approval process, we will support your communications and answer all questions from notified body and FDA.

We design and implement standard operating procedures that are compliant with international standards such as ISO 13485, ISO 14971 and IEC 62304, to ensure product safety, regulatory compliance, and customer satisfaction. We will work closely with your team to understand your specific needs and develop SOPs that are tailored to your business objectives to maximize your productivity and efficiency.