Design Control

SmartSolve® Design Control software enables life sciences organizations to conduct compliant medical device lifecycle management and improve product design quality. This collaborative solution forms an integrated quality ecosystem with other SmartSolve solutions.

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Collaborative software improves design quality and compliance.

SmartSolve® Design Control enables medical device manufacturers to provide documented evidence that a well-defined, controlled product design and development process is in place and has been properly executed. Our Design Control software helps you:

  • Record and review design evidence using policy-driven guided workflows to maintain control of your design process and ensure your organization fulfills appropriate medical device regulatory requirements.
  • Access design history records quickly by maintaining all your design data and documentation, from pre-market designs to post-market design changes, in one readily accessible, centralized place. 
  • Integrate with key quality systems to record design evidence, reference external documents and reports, or execute Medical Device Files and Risk Management tasks to help your organization reduce errors, cycle times, and audit findings, and improve end-to-end processes.
  • Complement current engineering processes, including your PLM or PDM system, as this highly flexible and configurable solution enables you to coordinate all your design control activities to ensure compliance. 

Learn how to manage and monitor your organization’s Design Control process in compliance with regulatory requirements. 

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