MD101’s regulatory diagnosis are designed for innovative healthcare startups and project leaders, enabling you to define the regulatory status of your product and the impact of regulations on the European and US markets. This service offers you support to: A. Classify and justify the class of your device. B. Establish a regulatory roadmap to obtain CE marking and FDA clearance. C. Support in ensuring that your device complies with applicable regulatory and standards requirements. D. Support in drawing up technical documentation for CE marking. E. Review and assistance in bringing your technical documentation in line with regulatory and standards requirements. F. Conducting risk analyses and helping you compile risk management files. G. Support for your registration: as a manufacturer, your devices are registered in EDAMED and the UDI positioned on your product. H. Assistance with the preparation of registration dossiers for Europe, the FDA, Health Canada or other national regulations.
3-day assignment for an audit to build a regulatory strategy and roadmap: €210/ hour.
Proposal for the assistance to build a technical dossier and quality management system: €1680 per day.
Intellectual Property & Legal
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Is this the service you are looking for? If so, you can apply to the service through EIC ACCESS+! Eligible applicants can also get co-funding through the EIC ACCESS+ initiative. Find out more on the project webiste.
Receive up to €60,000 in grants, covering up to 50% of the costs, to access specialised services from the EIC Service Catalogue. Learn more on the EIC ACCESS+ website.