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Change Control Management

ClinChoice offers best-in-class capabilities to support medical device innovators with complex technical and digital change requirements and maintain an edge in global markets quickly and frustration-free.

  • Full-service Change Control Management Solutions

    • Benefit-risk assessment of proposed changes based on the criticality
    • Assessment of the proposed changes to determine cost, effort, risk, and impact on product specifications, operations, and regulatory compliance
    • Documentation of analysis and decisions of various stakeholders with evidence for design controls and design changes to ensure alignment with business and market needs while maintaining regulatory compliance
    • Collaboration with multiple departments to collate documents for the closure of change requests
    • Creation of  templates for gathering information for procedures, processes, and product specifications
    • Authoring of justification to implement the necessary changes  in compliance with regulatory requirements
    • Preparation of change packets for submission to health authorities or notified bodies
    • Responses to health authorities or notified body queries
    • Support for changes in verification and validation of product design and manufacturing specifications