SmartSolve Design Control

Design Control Software – Compliant Medical Device Lifecycle Management

SmartSolve Design Control

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. This collaborative design control software improves design quality and compliance through tools that enable you to:

  • Record and review design evidence.
    Stay on top of key activities and design history. Design Control supports your product design and development processes by tracking all design evidence in a consolidated view. Our solution’s policy-driven workflows enable your team to maintain control of design processes by recording design phase activities sequentially or in parallel.
  • Access design history records quickly.
    By keeping all design data and documents in one place, your design history is always available. Design Control allows you to demonstrate process control and regulatory compliance by rapidly locating and extracting historical data, from pre-market design activities, to post-market data collection and subsequent design change records.
  • Integrate with key quality systems.
    Design Control and QMS together from a closed-loop product design and development process. Utilize SmartSolve’s quality ecosystem to experience improved processes that shorten cycle times and reduce errors and audit findings. Record and reference design evidence through integration with SmartSolve Document, Change and Risk Management to minimize design change risks and the likelihood of redesign.
  • Complement current engineering processes.
    Make the most of your PLM or PDM system as you experience the flexibility, scalability and configurability of Design Control. Complementing your current engineering systems, this adaptable solution allows the design control process to be implemented in alignment with the development of your medical devices. Continue to execute and manage your drawings, part list, specifications and all the data necessary to manufacture your device in your PLM, while Design Control manages your design process to ensure compliance with regulatory requirements.


Design Control is an integrated part of our SmartSolve quality management software.


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