Medical Device Quality Management

Quality Management for Medical Device Companies

Medical device and diagnostic companies face shorter product lifecycles, increased legal and regulatory scrutiny, and the need to manage partnerships across the supply chain. Sparta quality and compliance solutions help companies mitigate risks and reduce the complexity of managing associated processes.  They also help to lower the cost of the production, sales, and servicing of medical and diagnostic products. 

Companies can more easily comply with regulations like 21 CFR Part 11, 21 CFR Part 820, GMP, ISO13485, ISO9000, and other industry standards. And eliminate redundant systems and manual operations, while implementing consistent and automated best practices.

Learn why leading device manufacturers use Sparta to manage, track, and report on incidents.  And, to achieve compliance, manage the supply chain, reduce cycle time, and speed up time-to-market.  

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Quality Assurance

Ensure compliance, improve quality, and reduce costs by centralizing and integrating quality processes, including management and reporting.

Regulatory Affairs

Capture, manage, and track all communications, correspondence, product registrations, submissions, and commitments to health authorities. 

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