Medical Device and Diagnostic Industry (MD+DI)

Software Version Control for Medical Devices: Turning Traceability into Compliance Confidence

Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
MD&M East

Electronics Cleaning Validation: Ensuring Quality & Safety in Medical Device Manufacturing

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

Minkang Zhang Advances Medical Device Software Through DevOps Optimization and Lifecycle Management

A DevOps-based framework integrates automation, continuous integration, and agile methodologies to enhance medical device software development.
EurekAlert!

Almost half of FDA-approved AI medical devices are not trained on real patient data

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...