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Summary

Product Changes encompasses the systematic management of modifications to your medical device after market release. You implement structured change control processes through three key documents: Change Requests to initiate modifications, Bug Fix Reports to address software defects, and Change Evaluation Reports to assess the significance and impact of implemented changes.

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Regulatory Context

Under 21 CFR Part 820 (Quality System Regulation):
  • Design changes require design controls under Section 820.30(i)
  • Change control procedures must be established and maintained
  • Management approval required for design changes (820.30(i))
  • Changes must be documented and verified/validated as appropriate
  • Risk analysis must be updated for changes affecting safety or effectiveness
Special attention required for:
  • Changes that may require FDA notification or new 510(k) submission
  • Software changes affecting device classification or predicate comparison
  • Modifications impacting labeling, intended use, or contraindications
  • Bug fixes affecting safety-critical device functions

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Overview

Product Changes provides the foundation for controlled device evolution throughout your device’s post-market lifecycle. This card ensures that all modifications—whether driven by customer feedback, technical improvements, or regulatory requirements—follow systematic processes that maintain device safety and regulatory compliance. The Change Request serves as your gateway for initiating modifications, requiring cross-functional evaluation from product, quality, and business teams before implementation. This process prevents uncontrolled changes while ensuring proper impact assessment of proposed modifications. You use change requests to document the rationale for changes, identify affected products and components, and anticipate impacts on documentation, testing, and regulatory submissions. Bug Fix Reports address the unique requirements for resolving software defects in medical device applications. Unlike general software development, medical device bug fixes require regulatory-compliant documentation that demonstrates systematic investigation, risk analysis, and verification of corrections. These reports ensure that software defect resolution follows your change management process while maintaining traceability to your design controls and risk management systems. The Change Evaluation Report provides post-implementation assessment of changes to determine their regulatory significance and guide compliance decisions. This critical document evaluates whether implemented changes require notified body notification, affect CE marking validity, or necessitate FDA submissions. The evaluation process uses specific regulatory criteria to classify changes as significant or nonsignificant, directly impacting your ongoing market authorization. Together, these three documents create a comprehensive change control ecosystem that enables innovation while maintaining regulatory compliance. They provide auditable evidence of systematic change management, support post-market surveillance activities, and ensure that device evolution enhances rather than compromises safety and effectiveness. This systematic approach protects patients, maintains stakeholder confidence, and supports sustainable device improvement throughout the product lifecycle. The change management process integrates seamlessly with your broader quality management system, connecting to risk management for hazard assessment, design controls for verification requirements, post-market surveillance for trend analysis, and vigilance systems for safety reporting. This integration ensures that changes contribute to continuous improvement while maintaining the systematic quality approach required for medical device manufacturing.