Medical Device and Diagnostic Industry (MD+DI)

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
JD Supra

FDA finalizes computer software assurance guidance for production and quality system software

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
Business Wire

Sware Raises $6M to Accelerate Life Sciences Innovation by Automating FDA-Mandated Software Validation

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...
MD&M East

The Goldilocks Principle: Approaches to Software Validation

Software is a significant part of any modern manufacturing operation, and FDA requires validation of such software used for regulated processes. Companies are often confused, however, about when and ...