What Medical Device Companies Need to Know About DOJ Enforcement

Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and ...
Forbes

Medical Device Manufacturers Need To Act As Regulators Sharpen Their Cybersecurity Guidelines

Cybersecurity in healthcare is typically understood by the public as synonymous with ransomware attacks that shut down hospital operations or an employee mistake that leaks sensitive protected health ...
The Lancet

Bridging the gap: aligning clinical decision support regulation with clinical practice in the era of artificial intelligence

Clinical decision support (CDS) software plays an increasingly central role in health-care delivery, yet the ambiguous ...
MobiHealthNews

FDA floats new draft guidance, created by international group, on software as a medical device

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...