Bryan O’Donnell, Head of Quality at Gaelic Laboratories, explains how to navigate GMP challenges to ensure your company ...

Similarly, when medical device manufacturers require automated assembly systems for complex applications, they, too, turn to ...

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

CEO Scott Whitaker said “an exemption was provided for most medical devices during President Trump’s first term with respect to the tariffs on China, and we are advocating for a similar approach.” ...

Modular Medical (MODD) announced that BSI Group will serve as the notified body for the European regulatory clearance process…”The MODD1 ...

The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide valuable assistance to all ...

Located near Modena, Italy, Phoenix develops, assembles, and packages medical devices in just over 37,000 ft2 of manufacturing space and four ISO 8 clean rooms. The company is ISO 13485:2016 certified ...

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help ...

Eurofins CDMO Amatsiaquitaine S.A.S., the GMP manufacturer, to support Polyrizon in future ... stage biotech company specializing in the development of innovative medical device hydrogels delivered in ...

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...

The market for GMP-compliant cannabis vape products continues to expand. The number of medical cannabis patients in the UK is projected to increase by 124% from 2024 – 2028¹, and the German cannabis ...

Learn the principles, requirements, and expectations of Current Good Manufacturing Practices (CGMP) for medical device production. Topics covered include the regulatory definition of what constitutes ...