The global Pharmaceutical Quality Management Software Market, valued at US$1.41 billion in 2024, stood at US$1.59 billion in ...

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

Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and ...

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

Learn what the recently released CDSCO draft guidelines for medical device software within India actually mean.

Dublin, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The "Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS (Oct 23rd - Oct 24th, 2025)" training has been added to ...

Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...