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Summary

You must conduct systematic verification of all regulatory documentation and processes before releasing your medical device to ensure complete compliance with quality management requirements and market authorization conditions. Product release activities serve as the final quality gate that confirms your device is ready for safe commercial deployment while meeting all applicable regulatory obligations.

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Regulatory Context

Under 21 CFR Part 820 (Quality System Regulation), you must implement:
  • Design transfer verification per Section 820.30(h) confirming production readiness
  • Production and process controls per Section 820.70 ensuring quality manufacturing
  • Design history file completion per Section 820.30(j) before commercial distribution
  • Device labeling controls per Section 820.120 ensuring proper identification and instructions
  • Finished device acceptance per Section 820.80 confirming device specifications
Special attention required for:
  • Software validation completion per FDA software validation guidance
  • Cybersecurity documentation updates for software devices per FDA guidance
  • 510(k) substantial equivalence maintenance for predicate device changes
  • Post-market surveillance system activation per Section 820.100

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Overview

Product release represents the culminating milestone in medical device development where systematic verification confirms that all regulatory requirements have been met and your device is ready for safe commercial deployment. This comprehensive process transforms development outputs into market-ready products through rigorous documentation review, compliance verification, and quality system confirmation that provides confidence in device safety and regulatory compliance. Software Release Checklist Verification ensures systematic completion of all software development lifecycle requirements including design controls, verification and validation activities, risk management updates, and documentation currency. The software release checklist serves as a comprehensive quality gate that confirms all software requirements are properly implemented, tested, and documented according to IEC 62304 standards. This verification process includes confirming that version control procedures have been followed, that all testing activities demonstrate software functionality and safety, and that any identified anomalies have been properly evaluated and resolved through your established quality management procedures. Release Notes Documentation provides comprehensive communication about device changes, new features, resolved issues, and any important information that users or healthcare providers need to know about the new device version. Release notes serve as critical user communication that ensures proper device utilization while supporting post-market surveillance activities by establishing clear documentation of what changes were implemented in each device version. The documentation process requires synthesis of development activities, testing results, and risk assessment findings into user-friendly communication that supports safe device deployment. Device Label Creation and Verification ensures that all required identification, safety, and regulatory information is properly displayed on device packaging and within software interfaces according to applicable labeling requirements. Device labeling serves as the primary identification mechanism that enables traceability, regulatory compliance, and user safety by providing essential information including device identification, regulatory markings, safety warnings, and user instructions. Label verification requires systematic review against regulatory requirements while ensuring consistency with other device documentation and marketing materials. List of Medical Devices Management maintains comprehensive records of all device variants, software versions, and configuration options that are authorized for commercial distribution. This systematic device management enables effective post-market surveillance, regulatory reporting, and change control by providing clear identification and tracking of all devices that have been released to market. Device list management requires integration with UDI systems, regulatory registrations, and quality management procedures to ensure complete traceability and compliance throughout the commercial device lifecycle. Regulatory Registration Verification confirms that all required registrations have been completed with appropriate regulatory authorities before commercial distribution begins. Registration verification includes confirmation that FDA establishment registration and device listing activities are current, that EU competent authority and notified body notifications are complete, and that all market-specific requirements have been satisfied. This verification process prevents regulatory violations while ensuring that appropriate authorities are aware of your device’s commercial availability and can effectively conduct post-market oversight activities. Quality Management System Readiness confirmation ensures that all required procedures, personnel training, and system capabilities are in place to support commercial operations while maintaining regulatory compliance. Quality system readiness includes verification that manufacturing controls are validated, complaint handling procedures are operational, corrective and preventive action systems are functional, and post-market surveillance activities are prepared for implementation. This systematic readiness assessment ensures that commercial operations can maintain the same quality standards that were established during development activities. Documentation Package Completeness verification ensures that all regulatory documents are current, accurate, and properly controlled before device release. Documentation review includes confirmation that the technical file or design history file is complete, that all required testing and evaluation reports are finalized, that risk management documentation reflects final device configuration, and that clinical evaluation activities support the intended use and market claims. Complete documentation packages enable confident regulatory interactions while supporting ongoing compliance and post-market activities. Change Control Integration ensures that all device modifications implemented during final development stages have been properly evaluated, approved, and documented according to established change control procedures. Change control verification includes confirmation that any late-stage design changes have undergone appropriate risk assessment, that verification and validation activities address the changes, and that all affected documentation has been updated accordingly. Proper change control prevents uncontrolled modifications while maintaining regulatory compliance throughout the development-to-commercialization transition. Post-Market Surveillance Preparation confirms that systems and procedures are in place to monitor device performance, collect user feedback, and respond to safety issues after commercial deployment begins. Surveillance preparation includes verification that complaint handling procedures are operational, that adverse event reporting systems are functional, that post-market study protocols are implemented if required, and that personnel are trained on regulatory reporting obligations. Well-prepared surveillance systems enable proactive safety monitoring while supporting regulatory compliance and continuous improvement activities. Your product release activities must demonstrate systematic completion of all development requirements while providing confidence that commercial operations can maintain the same quality and safety standards that were established during device development. Effective product release processes prevent premature market deployment, reduce post-market risks, and support successful commercial launch by ensuring that all regulatory obligations have been systematically addressed before devices reach patients and healthcare providers.