Full-service solutions for medical devices and IVDs - examples of our services are listed below:
Let us navigate you through the regulatory landscape throughout the life cycle of your medical device and IVD. With offices in the EU as well as the US, and vast experience of both regulations we can provide you with a global perspective and hands on advice. Whether you need support identifying a suitable notified body, entering a new market, or making the transition from the medical device and IVD directive to the new EU regulation, we are here to support you.
We have extensive experience with all types of clinical investigations and can support you with clinical investigations regardless of product, clinical developmental stage and type of design. We support you with clinical investigations before as well as after CE-mark (PMCF) and can conduct investigations throughout the EU and the US.
Our medical writing team have extensive experience performing Clinical Evaluation Reports (CER) for all kinds of medical devices. We can support you finding the best way to prepare your CER in compliance with applicable regulations and guidelines. In addition, we can assist you with an efficient process to keep them up to date.
Within Biocompatibility and Toxicology, we can support you in every step from selecting the right biomaterial, planning and executing a Biological Evaluation and by setting up Toxicology and Risk assessment strategies. We guide you through the increased requirements and help you fullfil all applicable regulations.
Economic operators perspectives
Throughout your supply chain, the MDR has brought new requirements for Manufacturers, Authorized representatives, Importers and Distributors, together called Economic Operators. Partner with us to make sure you are up to date and compliant with the new regulations - or if you want us to act as an economic operator for you.
Our ecosystem for full-service medical device compliance
We are your full-service medical device partners. Together we offer unique expertise regarding Quality Assurance, Regulatory Affairs, Clinical Affairs, Biological Evaluations & Toxicology.