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