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Creating Paper Trails Without Paper: Making the Switch to Digital QMS

Creating Paper Trails Without Paper: Making the Switch to Digital QMS

With the increasing complexity of the medical device market, manufacturers are faced with an extensive list of product commercialization challenges ranging from mounting standards and regulatory changes, slow and expensive R&D, and supply chain disruption, to providing better cybersecurity features for new connected devices. The one common denominator that links these product development...

Inside Arena With Catie Jelinski: Spotlight on Quality, PLM, and Patient Care

Inside Arena With Catie Jelinski: Spotlight on Quality, PLM, and Patient Care

There’s no doubting the pandemic is driving disruption and innovation. Many industries have been forced to adapt or face disaster. One industry especially, life sciences, is undergoing significant transformation. New approaches that were used to speed up the development of COVID-19 vaccines and healthcare products are now being applied to other products. Life sciences companies are discovering...

Five Questions Every Medical Device Manufacturer Should Ask About QMS Solutions

Five Questions Every Medical Device Manufacturer Should Ask About QMS Solutions

What is QMS for medical devices? To help ensure that medical devices are safe for use and will function as intended, the FDA requires that manufacturers of these products establish and follow quality systems in accordance with current good manufacturing practices (CGMP). While the quality system regulation (QSR) does not prescribe how a manufacturer must produce a specific device, it does state...