The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...

SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced it has been awarded ISO 13485:2016 ...

Shenzhen Sungrow LED Technology Co., Ltd., the parent company of Wakelife Beauty, has recently secured the prestigious ISO 13485:2016 certification for its medical device quality management system.

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

The 2003 version of ISO 13485 is organized differently than the 1996 version. Much of the change is related to the prescribed process approach (as opposed to procedures or elements) and such a ...

SONGJIANG, SHANGHAI, CHINA, April 16, 2026 /EINPresswire.com/ — As global demand for high-quality personal protective equipment (PPE) transitions from emergency ...

THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with cleanroom injection molding and assembly. THY Precision offers medical device ...

CRANSTON, RI and PHOENIX, AZ--(Marketwired - Oct 15, 2015) - Nelipak® Healthcare Packaging ("Nelipak"), a global provider of custom thermoformed packaging that provides superior protection for medical ...