Practical reading for medical device founders navigating classification, AI and the road to market. Grounded in official sources. Written for the decisions ahead.
Compare FDA and EU MDR classification, understand Rule 11 for medical software, and prepare a market-specific regulatory plan.
Read article : US vs EU medical device classification: what founders need to knowLearn how FDA Predetermined Change Control Plans work, what an authorized PCCP can cover, and how founders can plan AI model updates.
Read article : Can you update your AI medical device without a new FDA submission?Understand FDA cyber-device requirements, the February 2026 cybersecurity guidance, and a practical preparation checklist for device founders.
Read article : Medical device cybersecurity in 2026: more than an SBOM