HealthTech & Medical Devices
Regulatory intelligence for healthtech and medical device companies
Navigate MDR, FDA 510(k), and global medical device regulations with AI. Cleo maps every certification requirement so your team focuses on patients, not paperwork.
Two solutions, one platform
Cleo covers both sides of regulatory intelligence for healthtech & medical devices.
Supplier & Partner Screening for HealthTech
Medical device companies work with specialized suppliers and clinical partners across the globe. Cleo screens every counterparty for sanctions, fraud history, debarment lists, and adverse events, ensuring your supply chain meets FDA and EU MDR integrity requirements.
- Screen suppliers against FDA debarment list and OIG exclusions
- Detect adverse events and quality enforcement actions in supplier history
- Beneficial ownership mapping for contract manufacturers
- Continuous monitoring aligned with MDR Article 10 vigilance obligations
Medical Device & HealthTech Product Compliance
Bringing a medical device to market requires navigating EU MDR, FDA 510(k)/PMA, and dozens of national regulations. Cleo generates a complete compliance matrix per product per market, with gap analysis, classification guidance, and certification timelines.
- Map EU MDR, IVDR, FDA 21 CFR, and PMDA requirements per device class
- Track clinical evaluation and post-market surveillance obligations
- UDI and labeling compliance across EU, US, and APAC markets
- Gap analysis with estimated certification timelines and costs
Explore by jurisdiction
See how healthtech & medical devices compliance varies across jurisdictions.
Ready to automate compliance for healthtech & medical devices?
See how Cleo maps regulations and screens third parties, in minutes, not months.