The Company’s comprehensive regulatory strategy includes multi-region approvals spanning pharmaceutical and digital health, both UK and U.S. clearances, with full ISO13485/ISO27001 quality ...

Closed Loop Medicine, a leader in pharmaceutical precision dosing, has promoted Kate Woolland to Chief Executive Officer. She was previously Chief Operating Officer for the company, which has ...

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company with development efforts focused on new products for rare diseases, today announced a partnership with Qureight ...

Amsino International Inc. announced the successful closing of transactions today to acquire the assets of MedXL Inc. and Liebel-Flarsheim Canada Inc. (collectively, "MedXL", or the "Company ...

LIVERMORE, Calif., Sept. 2, 2024 /PRNewswire/ -- Grepow, an innovator in battery technology since 1998, today announced a groundbreaking advancement in battery solutions: A new line of metal-cased ...

Russell Gilbert, managing director, Review Display Systems said, “After the hard work and investment to achieve ISO13485 accreditation at RDS, we are immensely proud of our accomplishment. The QMS ...

Abstract: This is the first report of sterile Thai silk fibroin (SF) solution (2-4% (w/v) in water) production at semi-commercial scale under the medical device management system conforming to ...

This ISO13485 certification will further increase the quality of Relu's product, besides reducing the regulatory work of their partners when integrating AI in their medical device software.

ISO13485 is the state of the art when it comes to best practices for medical device Quality Management Systems, and aligning to a standard that much of the rest of the world is using will help medical ...