The medical technology industry has gone through some changes in the last 14 years, as has its regulatory environment, and it was time that ISO 13485 reflected that evolution. The global standard for ...

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...

What is ISO 13458? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical device ...

The Critical Role of Parylene Coating in the Evolving Medical Industry The medical device sector is characterized by its uncompromising demands for precision, biocompatibility, and long-term stability ...

The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is ...

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...

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.

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 ...

BUFFALO GROVE, ILLINOIS / ACCESS Newswire / February 4, 2026 / PPC Flex, a leader in high-performance sterile and cleanroom flexible packaging solutions, is proud to announce that its Buffalo Grove ...