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Quality control

Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. more

16 Feb 2017 10:25

With MasterControl, Megadyne confidently demonstrates to regulatory bodies throughout the world how it complies with record retention, documentation and change control. more

26 Jan 2017 08:43 News

Caitlyn Scaggs, Polymer Solutions Incorporated, outlines the key aspects for consideration when choosing an independent testing lab more

25 Nov 2016 09:00 News

The latest edition of ISO 13485, the quality management systems standard for the medical device industry, has been published more

29 Feb 2016 10:49 News

Sam Anson Landscape

Source: Julian Brown, press and public relations photogtrapher, courtesy of UK-based charity Shelter.

Change control, also known as formula lockdown—the phenomenon whereby a supplier of a material agrees to provide a minimum period of notice before changing ingredients in a material formulation—helps OEMs manage quality. What's the best practice? more

3 Jun 2013 08:00 Opinion 4 Comments