PECB Signs a Partnership Agreement with Isometric Consulting
February, 2022 – PECB, a global provider of professional ISO standards trainings and certifications, has signed a partnership agreement with Isometric Consulting to expand its presence in North America market. Based on the agreement, Isometric Consulting will begin to provide services related to ISO standards. “This partnership addresses a specific market need. Organizations are looking to […]
The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485
Last week we reported the breaking news that the FDA, after years of attempts and delays, had finally released the proposed rule to harmonize the current Quality System Regulation (QSR) outlined in 21 CFR 820 with the international standard for medical device quality management system requirements, ISO 13485:2016 to generate a new resulting regulation called […]