Quality control

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

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


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


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


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? Read more

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