What is IEC 62304?
The IEC 62304 standard is a standard that specifies life cycle requirements for medical software and software within medical devices development.
Why is it important?
IEC 62304 is the main framework for requirements for the development and maintenance of medical software. It is harmonized by the European Union (EU) and the United States (US), and therefore it can be used as a reference to comply with regulatory requirements from both of these markets.
IEC 62304 covers all aspects of software development including, but not limited to, evaluating risks, developing requirements, design, implementation, verification, and maintenance.
We can work with you and help you with the following:
- Develop templates
- Release notes, Architecture design specification, requirements specification, test case specification
- Develop processes
- Software development lifecycle
- Release Process
- Change Control Process
- Requirements Management Process
- Hosting a workshop with your team and train your team
- Requirements Specification Session
- Risk Management Review
- Software Development Lifecycle