Your trusted source for medical device regulatory news, insights, and guidance. Helping professionals navigate the complex world of medical device compliance.
Our Mission
Medical Device Navigator was founded to democratize access to medical device regulatory information. Staying informed about regulatory changes and compliance requirements should be accessible to everyone in the industry.
Whether you’re a startup launching your first device, an established manufacturer expanding to new markets, or a regulatory professional seeking to stay current—we provide the news, analysis, and resources you need.
What We Cover
FDA Regulations
510(k) clearances, PMA approvals, De Novo classifications, warning letters, recalls, and guidance documents.
EU MDR & IVDR
European regulation updates, Notified Body activities, CE marking requirements, and EUDAMED developments.
Global Markets
Health Canada, MHRA, TGA Australia, Swissmedic, and other regulatory authorities worldwide.
Industry News
M&A activity, funding rounds, product launches, clinical trials, and business developments.
Why Trust Us
Content reviewed by regulatory professionals
Breaking news as it happens
Coverage from major markets
Unbiased reporting