Regulatory journey guidance for medical device innovators
Determine if a product is a medical device; Classify device risk level and generate formal classification PDF; Generate GSPR checklist for regulatory submissions; Identify required testing standards and testing houses; Support academic research teams in regulatory strategy; De-risk grant proposals with regulatory alignment; Guide start-ups through CE marking process
Built by University of Oxford; Trusted by University of Oxford, University of Cambridge, University of Birmingham, University of Bath, University of Glasgow, University of Southampton, University of Strathclyde, University of Nottingham, UCL, SDU; Recognized as 2025 Women in Business Award winner; Offers early access to AI features for registered users; Free initial classification check; Available in both EU and UK regulatory frameworks