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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...
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

Validating Software for Manufacturing Processes

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...
RAPS

Medical Device Validation: What You Need to Know and Why It's Important

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...