Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD companies inline with MDR, IVDR and FDA QMSR CHARLOTTE, NC, UNITED STATES ...

American Banknote Corporation (ABCorp), one of the longest-standing manufacturing service providers in the United States, has achieved ISO 13485:2016 medical device certification of its Additive ...

ISO 13485 is an internationally recognized standard for quality management systems, created by the International Organization for Standardization to ensure the safety and effectiveness of medical ...

FDA’s harmonization of the Quality System (QS) Regulation with ISO 13485 was long expected. It is welcomed by the global medtech companies, as other jurisdictions like the EU already use ISO 13485 as ...

ORCHARD PARK, N.Y. – Polymer Medical has achieved ISO 13485:2016 certification from NSF-ISR, an NSF company, distinguishing its quality management system, or QMS, for manufacturing medical devices.

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...

Abu Dhabi, UAE: ProvenMed announces today that it has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its innovative Med-Tech solutions. “We are ...

South African Health Products Regulatory Agency (Sahpra) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical-device license, with effect from 1 ...

SUZHOU, China—HBK, a global leader in test and measurement solutions, recently announced that its Suzhou production site has recently obtained ISO 13485 certification. ISO 13485 certification is a ...