Median Technologies (FR0011049824, ALMDT, "Median" or the "Company"), developer of eyonis®, a suite of artificial ...

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 ...

Today, Amcor, a global leader in developing and producing responsible packaging solutions, announced that its Winterbourne site, a center of excellence for medical and healthcare packaging, has ...

The FDA has notified the medical device manufacturing sector that ISO-13485(2016) will be recognized as a Quality Management System Consensus Standard. In February 2026, the FDA will move away from ...

RUTHERFORD, N.J., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.

Glucotrack, Inc., a medical technology company specializing in diabetes solutions, announced it has achieved ISO 13485:2016 certification from the British Standards Institute, marking a significant ...

GUELPH, ON / ACCESSWIRE / May 18, 2023 / Zentek Ltd. ("Zentek" or the "Company") ZTEKZEN, a graphene technology development and commercialization company has been granted ISO 13485:2016 Quality ...

Hoggan Scientific, LLC, a globally recognized leader in the design and manufacture of medical devices, is proud to announce that it has successfully received recertification for ISO 13485:2016, the ...

With the February 2, 2026 compliance deadline approaching, medical device manufacturers must prepare for FDA’s updated regulations. The new Quality Management System Regulation (QMSR) will replace the ...

Dual ISO certifications highlight Hatch's commitment to quality and innovation as a leading product development and contract manufacturing firm. We are thoroughly impressed by Hatch's sophisticated ...