Scope for IEC 62304 for Medical Device Software
Manufacturers of medical devices that include software must demonstrate compliance with IEC 62304 as part of the Regulatory approval process. Compliance can be achieved by implementing the standard processes and documenting evidence of adherence to its requirements.
Freyr’s IEC 62304 Key Services
Document Level Evaluation
An assessment of the overall documentation, ensuring completeness, clarity, and compliance with the Regulatory requirements. It includes a review of the structure, organization, and relevance of the documentation (such as Risk Management File, Software Description, etc.)
Software Description
A concise overview of the purpose, functionality, and intended use of the software associated with the medical device, providing a foundation for understanding its role in the device system.
Risk Management File
Documentation detailing the identification, assessment, and mitigation of potential risks associated with the software. It includes a comprehensive analysis of hazards and the implementation of risk control measures.
Software Requirement Specification
Detailed documentation outlining the functional and non-functional requirements of the software. It serves as a blueprint for software development, providing clear guidelines for expected behavior and performance. For e.g., risk management file, software design specification, system and software architecture design chart, software testing.
System and Software Architecture Design
A comprehensive description of the overall architecture of the device and its software components. This includes the relationship between different modules, interfaces, and how data flows within the system.
Software Design Specification
Detailed documentation specifying the design principles, data structures, algorithms, and interfaces used in the software. It serves as a guide for software developers to implement the intended functionality.
Software Development, Configuration, and Maintenance Practices
Documentation outlining the processes and practices employed during software development, configuration management, and maintenance. It includes procedures for code development, version control, and ongoing support.
Software Testing as part of the Verification and Validation
A comprehensive overview of the testing methodologies employed to verify and validate the software. This includes unit testing, integration testing, system testing, and validation testing to ensure the software meets its intended requirements.
Software Version History
A record of the chronological development of the software, including version updates, enhancements, and bug fixes. It provides a historical perspective on the evolution of the software
Unresolved Software Anomalies
Documentation highlighting any outstanding issues, anomalies, or defects within the software that have not been fully addressed. It includes an explanation of the impact and potential mitigations.
Medical Device Regulatory Consulting – Proven Expertise
Performance Evaluation for Medical Devices Overview
- Comprehensive Regulatory strategy for SaMDs.
- Regulatory and market intelligence support.
- Product classification and registration services for SaMDs.
- Regulatory support for SaMD product development documents.
- Consultation services on SaMD clinical evaluation studies.
- Post-approval change management.
- Local representation service.
- Successful submissions for various classes of SaMDs.
- Dedicated and expert personnel to provide medical device and IVD Regulatory support.
- On-time submission of deliverables.
- Local affiliate access to meet the challenges of the authority and language-specific requirements.
- In-country or legal representative support with a cost-effective model.
- Regulatory resource management/staff augmentation support.
