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 ...

India’s drug regulator CDSCO has issued final guidance on medical device software under MDR-2017, clarifying SaMD vs SiMD rules, Algorithm Change Protocol for AI updates, and licensing processes. The ...

CDSCO releases final guidance document on Medical Device Software: Gireesh Babu, New Delhi The Central Drugs Standard Control Organisation ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

Teamcenter provides SMT with a centralised digital infrastructure that connects data from engineering, quality, and programme management into a single location.

CDSCO clarifies regulatory pathways for AI and software-based medical devices under the Medical Devices Rules, ensuring ...

The software supply chain is critical to ensuring a secure medical device that can prevent injury, according to Gregg Van Citters, MS, PhD, a principal software quality engineering consultant at ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

The technology licensing transaction was reviewed, evaluated, and approved by the independent members of Borqs' Board of Directors in accordance with standard corporate governance and related-party ...

On July 14, the U.S. Food and Drug Administration (FDA) announced it is seeking public input regarding the patient safety impacts of certain ...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Propel Software, creator of the first product value management (PVM) platform that transforms how businesses create, market, sell, and service products, has ...