Last updated on April 2nd, 2025 at 01:24 pm
ISO/IEC 62304 signifies the lifecycle requirements for medical device software. It develops and maintains the life cycle process of medical device software.
ISO 62304 is also known as SaMD (Software as a Medical Device). It provides a framework, ensuring that the software is reliable and safe.
Also, it outlines the requirements for stand-alone and embedded software. ISO 62304 also helps to ensure the software’s safety.
ISO Certification in 24 Hours – Fast and Easy!
Contact Us Today!
Hire the Best ISO Certification Consultant Call +91 9314321001
What is the ISO/IEC 62304 standard?
ISO/IEC 62304 is also known as IEC 62304. It defines the requirements of medical device software. It signifies the life cycle process of the medical device. ISO 62304 Certification helps to ensure effective and safe software development. It gives a framework to manage the entire lifecycle.
Why ISO/IEC 62304 is important
ISO/IEC 62304 is important because it ensures the reliability, safety, and quality of the software used in medical devices. It helps to provide a systematic framework for software development. It helps to reduce risks for the organization.
Who can apply for ISO/IEC 62304?
ISO/IEC 62304 is applied only to companies that manufacture, maintain, and design medical device software. Like-
- Software developers for Medical devices
- Medical device manufacturers
- Software maintenance and support companies
- Medical device integrators
- OEMs and suppliers
- Medical device testing and validation service providers
- Medical device startups and innovators
- Contact manufacturers for Medical devices
What are the benefits of the ISO/IEC 62304?
- Improves software quality
- Regulatory compliance
- Safety assurance
- Reduce risk
- Global harmonization
- Ensures patient safety
Key aspects
ISO 62304 Software Classification
- Class A- Software that must not have any impact on patient safety.
- Class B- Software that can have a moderate impact on patient safety.
- Class C- software that has a high impact on patient safety.
Software development life cycle
ISO 62304 signifies the important phases of the lifecycle of software development. These important phases are-
- Software planning
- Analyse the requirements of the software
- Design of software
- Implementation of software
- Validation and verification of software
- Maintenance of software
- Decommissioning of software
Risk management
Risk management is an important component of ISO/IEC 62304. ISO/IEC 62304 incorporates the principle of ISO 14971. This includes-
- Risk assessment
- Risk control
- Mitigation of risk
- Identification of risk
Configuration management
It ensures that the changes made in the software should be tracked and controlled through its life cycle. Configuration management activity includes-
- Software artifacts control version
- Details should be maintained of the changes in the software with reasons.
- It ensures that the right version of software is being used in testing and production.
Verification
Verification means that software is developed and made according to the requirements of medical devices.
Includes-
- Unit testing
- Integration testing
- System testing
- Reviews
- Code reviews
- System testing
Validation
It means the software should work to meet the customer’s needs and should work correctly in the operational environment.
What are the requirements of the ISO/IEC 62304 standard?
- Software development process requirements
- Risk management of software
- Maintenance of software
- Software configuration management
- Testing and integration of software
- Documentation requirements ofthe software
- Human factors engineering requirement
ISO 62304 Certification Process
- Software development planning-
- Signify the software safety classes (Classes A, B, and C).
- Prepare a plan for the software development life cycle, and make sure that all phases are covered in it.
- Recognize the required resources, like tools, human resources, and infrastructure.
- Requirements definition-
- Collect all the documents.
- Signify software functionality and user needs clearly.
- Ensure traceability from requirements through validation, design, and testing
- Software design-
- Generate a high-level software architecture.
- Design and develop a detailed data structure based on the requirements.
- Ensure that the safety-criticals are identified and managed properly.
- Software implementation-
- Create a software code based on design documents.
- Use proper programming languages, platforms, and tools.
- Execute any necessary code to ensure that the safety requirements meet with the software.
- Ensure code review, consistency, and quality assurance with requirements.
- Verification
- Perform unit tests to ensure that each component is working deliberately.
- Perform integration testing to ensure that software components are working together properly.
- Perform system-level testing to ensure that each system function meets the requirements.
- Validation- Ensure compliance with safety and regulatory requirements with testing.
- Release and maintenance-
- Prepare the software for release.
- Release the software to the deliberate markets or users, ensuring regulatory compliance.
- Manage the software with regular updates.
- Execute a change management software to assess the impact of changes.
- Risk management-
- Identify the risk related to software
- Execute risk control to reduce the risks.
- Regularly check for the risks in the software, specially after updates or changes in the software.
- Documentation and traceability-
- All activities must be documented to ensure traceability with regulatory requirements.
- Include all the documents of planning, requirements, design, verification, validation, testing, and maintenance.
Documents required for ISO/IEC 62304
- Detailed design
- Unit implementation
- Development plan
- Requirements specification
- Architecture
- Verification of unit
- Software release
- Software testing
- Integration testing of software
- User requirements
- Object code
- System requirements
- Source code
- Model
- Risk management plan and file
- Information related to safe use
- Installation manual
- Quick reference guide
- Technical description
- Important details, in case of import
Cost of ISO 62304 Certification
The cost of ISO 62304 depends on the size and complexity of the organization and certification body and also includes the ISO standard fee.
Validity of ISO 62304
3 years
Processing time
From A Star Legal Associates, you will get ISO 62304 within 24 hours.
ISO 62304 Certification Consultants
A Star Legal Associates provide ISO/IEC 62304 certificate in India. ISO/IEC 62304 signifies the requirements of medical device software. So, if you also to apply for ISO/IEC 62304 in India you can consult with A Star Legal Associates. We provide you with a complete guide about ISO/IEC 62304.
Hire the Best ISO Certification Consultant Call +91 9314321001
Conclusion
ISO/IEC 62304 helps organizations to develop and maintain medical device software. The 62304 certification also covers two types of software for medical devices. The first software is stand-alone software, and the second software is embedded software. This certification also helps medical devices to check the validity and maintenance of the software. This also makes it easier for medical devices to detect errors.
FAQ
What does SaMD stand for in ISO/IEC 62304
SaMD stands for Software as a Medical Device.
In which international standard are the life cycle requirements for medical device software described
ISO/IEC 62304.
Which is the most commonly used software for medical devices
Electronic Health Record (EHR) software is the most commonly used software in medical devices.
Full form of IEC
IEC stands for International Electrotechnical Commission
Current version of ISO/IEC 62304
The current version of ISO/IEC 62304 is ISO/IEC 62304:2006/AMD 1:2015.