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Updated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in the Federal Register (FR). This year, being the year we
Enjoy our Second global standards & regulatory update. It provides you with tools to help strategically plan for regulatory & standards updates for the Medical Device Industry Let’s start with some really big news!!! It is anticipated in 2019 IEC 60601-1 edition
This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015. Health Canada updated their list of Recognized Standards for Medical Devices on August 31, 2015. The changes included additions, updates and removals to the listing.
Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines? How much time does it take to put this list together and how much