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--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.

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

CDSCO releases new draft guidelines aligning India's regulatory framework for medical device software with global standards. Lobby group seeks clarity on evaluation protocols for AI-ML devices.

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 ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Dublin, Sept. 24, 2025 (GLOBE NEWSWIRE) -- The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course (Nov 10th - Nov 11th, 2025)" training has ...

The Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document on the conduct and regulation of Medical Device Software (MDSW) under the Medical Devices Rules (MDR), ...

(MENAFN- GlobeNewsWire - Nasdaq) This seminar offers medical device manufacturers the opportunity to enhance efficiency and compliance by applying Lean Documentation and Lean Configuration principles.

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 ...