Medical Devices
Medical device compliance, from EU MDR to FDA 510(k) and global markets
Bringing a medical device to market means MDR 2017/745, IVDR, FDA 510(k)/PMA, PMDA, NMPA, UDI, ISO 13485, ISO 14971, and clinical evaluation: for every class, every market. Cleo maps each certification, declaration, and post-market surveillance obligation per device per country, so your regulatory team ships faster and stays audit-ready.
Product compliance
One platform for every market
Cleo maps regulatory obligations for medical devices across 106 countries.
Medical Device Product Compliance & Global Certification
Launching a medical device across the EU, US, Japan, China, Brazil, and Korea means EU MDR 2017/745, IVDR 2017/746, FDA 21 CFR Part 820, 510(k)/PMA/De Novo, PMDA shōnin, NMPA registration, ANVISA RDC 751/2022, and MFDS approvals: each with different classification rules, clinical evidence requirements, and UDI conventions. Cleo builds a complete compliance matrix per device class per market, with classification guidance, clinical evaluation gap analysis, and certification timelines.
- Map EU MDR, IVDR, FDA 21 CFR 820, PMDA, NMPA, ANVISA, MFDS, and 25,000+ regulations per device class
- Automated device classification (Class I/IIa/IIb/III, MDR Annex VIII, FDA product codes) with substantiating logic
- UDI assignment and labelling compliance across GUDID, EUDAMED, and national UDI databases
- Clinical evaluation and post-market clinical follow-up (PMCF) obligation tracking under MDR Article 61
- ISO 13485 quality system gap analysis with audit-ready evidence and CAPA workflow integration
Jurisdictions
Explore by jurisdiction
See how medical devices compliance varies across jurisdictions.
By profile
Whether you manufacture, import or sell on a marketplace
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See how Cleo maps regulations and screens third parties, in minutes, not months.