Overview
Summary
Establishing a Quality Management System (QMS) forms the regulatory foundation of your medical device company, providing systematic procedures that control every aspect of your device lifecycle from design through post-market surveillance. Your QMS demonstrates to regulatory authorities that you have consistent processes, defined responsibilities, and measurable quality objectives that ensure patient safety and regulatory compliance.
Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Quality management system is mandatory for all medical device manufacturers
- Must establish document and record controls (820.40) for all QMS procedures
- Management responsibility requirements (820.20) including designated management representative
- Design controls (820.30) required for Class II and III devices
- Manufacturing controls (820.70) and corrective/preventive actions (820.100)
Special attention required for:
- Responsible Corporate Officer Doctrine - executives remain personally liable for QMS failures
- Design History File maintenance for devices subject to design controls
- Electronic record compliance (21 CFR Part 11) if using electronic QMS systems
- Software medical devices require integrated software lifecycle procedures (IEC 62304)
Under 21 CFR Part 820 (Quality System Regulation):
- Quality management system is mandatory for all medical device manufacturers
- Must establish document and record controls (820.40) for all QMS procedures
- Management responsibility requirements (820.20) including designated management representative
- Design controls (820.30) required for Class II and III devices
- Manufacturing controls (820.70) and corrective/preventive actions (820.100)
Special attention required for:
- Responsible Corporate Officer Doctrine - executives remain personally liable for QMS failures
- Design History File maintenance for devices subject to design controls
- Electronic record compliance (21 CFR Part 11) if using electronic QMS systems
- Software medical devices require integrated software lifecycle procedures (IEC 62304)
Under EU MDR 2017/745:
- Quality management system required for all manufacturers (Article 10(9))
- Must comply with EN ISO 13485:2016 harmonized standard requirements
- Person Responsible for Regulatory Compliance (PRRC) integration mandatory
- Technical file maintenance throughout device lifecycle (Article 11)
- Post-market surveillance system integration (Articles 83-86)
Special attention required for:
- Notified body QMS assessment requirements for higher-risk devices
- Clinical evaluation and post-market clinical follow-up integration
- UDI system compliance and EUDAMED registration requirements
- Authorized representative roles for non-EU manufacturers
Overview
Your Quality Management System establishment involves creating and implementing comprehensive procedures that form the backbone of regulatory compliance and operational excellence. This foundational card encompasses 27 critical tasks that collectively establish your systematic approach to quality management, from high-level policy documents to detailed operational procedures.
The Quality Manual and Policy Objectives serves as your QMS cornerstone, establishing organizational commitment, management structure, and measurable quality targets that guide all subsequent activities. This foundational document demonstrates to regulators and stakeholders that your organization has systematic leadership and clear accountability for quality outcomes.
Document and Record Control procedures establish the critical infrastructure for managing all quality documentation throughout its lifecycle. These procedures ensure that teams always use current, approved versions of procedures while maintaining complete traceability and audit trails required for regulatory compliance and effective change management.
Your Design Control procedures provide the systematic framework for medical device development, ensuring that products meet user needs and regulatory requirements through controlled design inputs, outputs, verification, validation, and transfer processes. This structured approach transforms device development from ad-hoc engineering into a regulated process that builds regulatory confidence.
Software-specific procedures address the unique challenges of software medical devices through integrated development lifecycles, problem resolution, validation, and cybersecurity management. These procedures ensure that software development follows recognized standards like IEC 62304 while maintaining compatibility with overall quality management requirements.
Risk Management procedures integrate systematic hazard identification, risk assessment, and control measures throughout your device lifecycle. These procedures ensure compliance with ISO 14971 while providing practical frameworks for identifying, evaluating, and mitigating risks before they impact patients or business operations.
Human Resources and Training procedures establish competency requirements, training programs, and personnel qualifications that ensure your team has the knowledge and skills necessary for quality-critical activities. These procedures address both initial training and ongoing competency maintenance throughout employee tenure.
Operational procedures cover critical business processes including manufacturing controls, purchasing and supplier management, sales activities, and deployment procedures. These procedures ensure that business operations maintain quality standards while supporting efficient commercial activities and regulatory compliance.
Change Management procedures provide systematic approaches for evaluating, implementing, and monitoring changes to products, processes, or quality systems. These procedures ensure that changes undergo appropriate risk assessment and approval before implementation while maintaining complete traceability for regulatory purposes.
Post-market procedures establish comprehensive systems for monitoring device performance, managing customer feedback, implementing corrective and preventive actions, and conducting regulatory vigilance activities. These procedures ensure ongoing safety monitoring and continuous improvement throughout your device’s commercial lifecycle.
Clinical and Performance Evaluation procedures define systematic approaches for demonstrating clinical safety and performance throughout development and post-market phases. These procedures ensure that clinical evidence generation meets regulatory requirements while supporting marketing claims and safety monitoring.
Internal Audit procedures establish independent assessment capabilities that verify QMS effectiveness and regulatory compliance. These procedures provide systematic approaches for conducting audits, managing findings, and implementing improvements that strengthen your quality management system.
Regulatory Management procedures ensure systematic tracking of regulatory requirements, product registration activities, and certification maintenance. These procedures provide frameworks for staying current with evolving regulations while maintaining compliance across multiple jurisdictions and product lines.
Each procedure within this comprehensive framework connects to create an integrated quality management system that supports efficient operations while ensuring regulatory compliance. The procedures establish clear roles, responsibilities, and interfaces between different organizational functions while providing practical guidance for daily activities. Your implementation approach should prioritize core procedures first, then systematically build additional capabilities as your organization grows and product portfolio expands.
This systematic approach transforms quality management from a compliance burden into a strategic enabler that supports business growth, regulatory confidence, and ultimately better patient outcomes through safer, more effective medical devices.