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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...
Fulfilling safety and environmental regulations, procuring components with existing supply chain concerns, and meeting quality requirements are all challenges that have electric vehicle (EV) manufacturers turning to digital solutions and processes to help them collaborate across the supply chain. Digital transformation is core to being successful nowadays; a digital backbone can transform the...
The regulatory landscape for electric transportation is becoming increasingly complex as electric vehicles (EVs) continue to gain momentum and new technologies emerge. Keeping track of the ever-changing requirements can be overwhelming for EV manufacturers due to the compressed timelines, part shortages, and other obstacles they face in getting products to market. Failure to comply with...
