Developing an AI digital therapeutic that meets both FDA Part 820 and ISO 13485 requirements is a complex but...
post-market surveillance
Digital therapeutics (DTx) sit at the intersection of healthcare and technology, demanding rigorous evidence to prove safety,...
In 2025, the regulatory landscape for AI‑driven medical diagnostics is tightening, with the FDA’s Quality System Regulation...
Securing CE marking for a digital health trial app under the Medical Devices Regulation (MDR) can be...
When a medical device is software‑only and intended to support clinical trial operations, the FDA classifies it...
Securing reimbursement for a digital therapeutic in the European Union requires more than meeting the Medical Device...
The rise of continuous‑learning AI and self‑updating digital health tools has forced regulators and manufacturers to rethink...
Living Algorithms are software systems that continue to learn and adapt after market release; designing continuous real‑world...