MediTest Genesis AI

Automated Healthcare Test Case Generation

Compliance Hub

Healthcare regulatory standards integrated into every test case

Regulatory Compliance by Design

MediTest Genesis AI ensures every AI-generated test case aligns with international healthcare standards including FDA, IEC, ISO, and HIPAA requirements. All test cases include compliance tags, traceability IDs, and validation criteria required for regulatory submissions.

Supported Compliance Standards

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FDA 21 CFR Part 820

Quality System Regulation

Ensures medical device software follows FDA's Quality System Regulation, covering design controls, risk management, and validation processes.

Key Requirements:

Design validation and verification
Risk analysis documentation
Change control procedures
Traceability matrix maintenance

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IEC 62304

Medical Device Software Lifecycle

International standard for medical device software development lifecycle processes, defining software safety classification and development requirements.

Key Requirements:

Software safety classification (A, B, C)
Software development planning
Architecture and detailed design
Unit and integration testing

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ISO 13485

Medical Devices QMS

Quality management system standard specific to medical devices, ensuring consistent design, development, production, and delivery.

Key Requirements:

Document and record control
Risk management integration
Design and development validation
Post-market surveillance

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ISO 9001

Quality Management Systems

General quality management standard ensuring organizations meet customer and regulatory requirements through effective processes.

Key Requirements:

Quality policy and objectives
Process approach implementation
Continual improvement focus
Customer satisfaction measurement

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ISO 27001

Information Security Management

Information security management standard protecting sensitive data through risk assessment and security controls.

Key Requirements:

Information security policies
Risk assessment procedures
Access control measures
Incident management protocols

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HIPAA Compliance

Health Insurance Portability

US healthcare data privacy and security standards ensuring protection of patient health information (PHI).

Key Requirements:

PHI encryption at rest and in transit
Access controls and audit logs
Business associate agreements
Breach notification procedures

How We Ensure Compliance

Automated Compliance Tagging

Every test case is automatically tagged with relevant compliance standards

Traceability Matrix

Full requirement-to-test-case traceability for audit readiness

Validation Documentation

AI-generated test cases include validation criteria per regulatory requirements

Risk-Based Testing

Test case severity and priority aligned with IEC 62304 safety classifications

Important Notice

While MediTest Genesis AI generates test cases aligned with regulatory standards, all AI-generated content requires human review and validation by qualified healthcare QA engineers before use in regulatory submissions or production environments. This tool assists in compliance but does not replace professional regulatory expertise.

Additional Resources

Regulatory Guidance

Access FDA, IEC, and ISO documentation

Training Materials

Learn about compliance best practices

Audit Support

Prepare for regulatory inspections