Salt Medical today announced it has achieved ISO 13485:2016 certification, the internationally recognised standard for quality management systems for the medical device industry.

Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

Medical device development leaves no room for mistakes. It demands coordinated execution across hardware, embedded software, cybersecurity, validation, and quality management syst ...

Over the last 15 years, ISO 10993-18 has become a notable resource for professionals at each stage in the supply chain and manufacturing of medical devices, assisting them in the evaluation of ...

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 2015 revision of the ISO 9001 quality standard contains fundamental changes to the structure and contents of the standard and offers a preview of some revisions to ISO 13485 expected in the coming ...

DUBLIN--(BUSINESS WIRE)--Presbia PLC (NASDAQ:LENS), an ophthalmic device company and leader in near-vision restoration, achieved a major milestone towards complying with the revised ISO (International ...

MANILA, Philippines - On March 27, 2009, the National Kidney and Transplant Institute (NKTI) Medical Laboratory made a significant milestone in the history of diagnostic medicine in the country as it ...