Health Software - Requirements of IEC 82304 1 - General Requirements for Product Safety
This course provides a clear and practice oriented introduction to IEC 82304 1, the central standard for health software and software as a medical device (SaMD). Participants learn how to apply the standard’s requirements to standalone software, mobile medical apps, and non medical health software. The training explains how IEC 82304 1 integrates with IEC 62304, ISO 14971, and ISO 13485, and how its expectations for safety, security, usability, and documentation can be implemented throughout the software lifecycle. Practical examples and real world insights help participants create compliant technical documentation and validation evidence.
Course Outline
- Regulatory foundations for health software and SaMD
- Key terminology and scope of IEC 82304 1
- Safety, security, usability, and IFU requirements
- Software lifecycle processes and integration with IEC 62304
- Validation of standalone software and mobile medical apps
- Interfaces with ISO 14971 and ISO 13485
- Technical documentation and development file structure
- Practical examples and implementation strategies
Learning Outcomes
Regulatory Foundations
- Introduction to regulatory requirements for software as a medical device
- Distinction between medical and non medical health software
- Overview of relevant international regulations and expectations
Terminology and Definitions
- Key terms used in IEC 82304 1
- Understanding the classification and scope of health software
Scope and Requirements of IEC 82304 1
- Application areas and boundaries of the standard
- Requirements for product safety and information security
- Usability and instructions for use
- Documentation and evidence requirements
Software Lifecycle Processes
- Lifecycle phases according to IEC 82304 1
- Integration with IEC 62304 software development processes
- Validation of standalone software and mobile medical apps
- Managing updates, maintenance, and configuration
Interfaces to Other Standards
- IEC 62304 (software lifecycle processes)
- ISO 14971 (risk management)
- ISO 13485 (quality management systems)
- Usability engineering and clinical evaluation interfaces
Validation and Technical Documentation
- Validation requirements for SaMD and health software
- Content of a development file according to ISO 13485
- Documentation for regulatory submissions
- Practical examples and best practices
Why You Should Attend
This course is ideal for professionals who need a clear understanding of how to apply IEC 82304 1 to health software and SaMD. It equips participants to implement lifecycle processes, create compliant documentation, and integrate safety, security, and usability requirements into development workflows. Practical examples and implementation strategies help ensure that software products meet regulatory expectations and are ready for market access.
Who Should Attend
Who Should Attend
- Medical device manufacturers
- Software developers
- Auditors and PRRC (Article 15, MDR)
- Quality Management professionals
- Regulatory Affairs specialists
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