Medical Devices and Combination Products
We provide specialized expertise in the complex regulatory landscape of Combination Products, including comprehensive support for Article 117 documentation to ensure compliance with medicinal product requirements where applicable. Our services extend to the critical clarification of borderline products, helping you determine the correct regulatory pathway for devices that may straddle definitions or incorporate medicinal substances. Furthermore, we guide you through the process of obtaining Notified Body Opinions, ensuring a clear and compliant market entry strategy for your products.
From initial concept to market launch and beyond, we guide you through the intricacies of Medical Device, Combination Product, and In Vitro Device (IVD) development. This includes the crucial clarification and definition of your Regulatory Strategy, establishing the definition of Design Input Requirements and User Requirements to ensure your product meets user needs and technical specifications. We also offer assistance with Quality Management Systems (QMS) and support for Software as a Medical Device (SaMD). We help establish solid Quality Agreements, manage supplier responsibilities including supplier auditing, and facilitate interactions with Health Authorities to ensure your products reach the market efficiently and compliantly.
Our team excels in the development and review of robust Technical Documentation (DHF Documentation) essential for regulatory approval. This includes conducting thorough Clinical Evaluations to demonstrate safety and performance, and implementing comprehensive Risk Management processes throughout the product lifecycle. We assist in drafting and meticulously reviewing all necessary documents to meet stringent regulatory standards.
