The new ISO 9001:2015 standard and the anticipated reboot of ISO 13485 could create hurdles for medical device manufacturers. Thomas C. Bowles Recent months have seen extraordinary changes in the ...

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 ...

To achieve a comprehensive quality management system for designing and manufacturing medical devices, manufacturers are increasingly achieving ISO 13485 certifications. Officially designated as ISO ...

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...

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 ...

Stability Biologics, LLC has successfully achieved ISO 13485:2016 certification for its Quality Management System. SAN ANTONIO, TX, UNITED STATES, March 24, 2026 ...

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 ...

PERKASIE, Pa.--(BUSINESS WIRE)--US BioDesign, a global leader in the production of biomedical textile structure components today announced that they have received their ISO 13485:2003 Certification.