For manufacturers of artificial intelligence-enabled Software as a Medical Device (SaMD), the hardest compliance question in 2026...
ISO 13485
Software as a Medical Device (SaMD) developers working with artificial intelligence and machine learning components face a...
Developing an AI digital therapeutic that meets both FDA Part 820 and ISO 13485 requirements is a complex but...
For developers of digital health applications, 2024 marks a pivotal year where the convergence of U.S., European,...
In 2025, developers building digital health software must navigate two distinct regulatory frameworks—EMA’s European Medicines Agency and...
In 2026 the regulatory environment for digital health tools used in clinical trials has become more streamlined,...
When launching an AI‑powered diagnostic mobile app in the European Economic Area, developers face two parallel streams...
Securing reimbursement for a digital therapeutic in the European Union requires more than meeting the Medical Device...