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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The ...

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

Document Control Systems Inc. (DCS), a Salt Lake City-based provider of integrated quality management software solutions, is offering a free white paper and downloadable presentation discussing ...

The draft is a near total overhaul of the document finalized by FDA in 2005, with only short sections on topics such as software verification and the history of software revisions surviving unchanged.

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 ...

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, ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions ...

The guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and ...

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 ...