Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
CEO and co-founder, Dave DeRam shared feedback from a recent call, “To have a single source of truth for making design decisions and standing up to an FDA audit is a game changer within the industry.” ...
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...
Has CDSCO Guidance Changed The Rules? Legal News and Analysis - India - Regulatory & Compliance - Conventus Law ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
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