Documentation provided to regulatory bodies prior to marketing medical device software serves as a comprehensive explanation of the software’s design, functionality, and safety aspects. This documentation typically includes source code, algorithms, verification and validation data, and risk assessments, illustrating how the software meets specified requirements and mitigates potential hazards. For example, a software component controlling an insulin pump would require extensive documentation of its closed-loop control algorithm and safeguards against over-delivery of insulin.
Thorough and well-organized documentation is essential for regulatory review, ensuring that medical device software is safe and effective before it reaches patients. It provides transparency and enables regulators to assess the software’s compliance with applicable standards and guidelines. This process has evolved significantly over time, reflecting increasing software complexity and a greater understanding of potential risks. The meticulous review of this information allows regulators to make informed decisions, safeguarding public health.
