In the 2024 Form 483s, the FDA deemed certain of the company ... a systematic and holistic approach to improving its quality management system across its manufacturing and supply network.

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.

The ISO 13485 standard is essential for ensuring the safety and effectiveness of medical devices and aligns with the recent U.S. FDA Quality Management System Regulation that harmonizes U.S. and ...