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

While the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”) primarily focusses on the pre-approval stage of a medical device and how the manufacturer can ...

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 ...

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 ...

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

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 ...