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 ...
Ocutech, Inc. announced that it has achieved ISO 13485:2016 certification, an internationally recognized standard for quality ...
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 ...
FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...
For years, the medical device industry has been expecting the alignment of FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. FDA issued a proposed rule ...
YOKNEAM ILLIT, Israel--(BUSINESS WIRE)--ForSight Robotics, the pioneer in ophthalmic robotic surgery, announced today its achievement of ISO 13485:2016 certification, an international benchmark for ...
Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to ...
BUFFALO GROVE, ILLINOIS / ACCESS Newswire / February 4, 2026 / PPC Flex, a leader in high-performance sterile and ...
THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with ...
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