Before adding AI to a medical device, consider clinical need, data quality, safety, usability, updates, lifecycle cost, and market value. The FDA has authorized more than 1,600 AI-enabled medical devices for marketing in the United States as of September 2026. For medical device startups, adding AI can improve diagnostic capabilities, clinical workflows and product performance. However, it also introduces challenges involving clinical data, validation, usability, hardware int

Infographic outlining the 7 critical cost and timeline factors for ISO 13485 medical device certification in India A medical device startup has spent months developing its product. The prototype works. Suppliers are being shortlisted. Manufacturing conversations have started. Then comes another line in the commercialisation plan: ISO 13485 certification. Someone adds a certification fee to the budget and a few weeks to the timeline. That number may turn out to be the least in