Training Duration: 2 Days
What Will You Learn?
This course presents IEC 62304, Amendment 1 and IEC 82304-1 in a practical and accessible way. Implementing these software standards can pose a challenge for many medical device manufacturers due to the extensive and sometimes new processes required. This training provides a foundational overview of the key standard requirements and the essential software lifecycle processes. Through practical exercises, participants will deepen their understanding of the standards and practice implementation related to process design and documentation. The course aims to equip you with the knowledge to develop, approve, and maintain medical software in full compliance with applicable standards.
Course Outline
- Introduction to Medical Device Software
- Conformity Assessment Procedure Requirements for Medical Device Software
- Key Definitions and Terminology
- Detailed Requirements from IEC 62304, Amendment 1:2015 and IEC 82304-1
- Software Safety Classification
- Software Development Process
- Software Maintenance Process
- Software Risk Management Process
- Software Configuration Process
- Software Problem Resolution Process
- Verification Methods
- Integration with Other Standards and Validation Processes
- Practical Implementation of Standards in Existing Medical Software
- Determining the State of the Art (STOA)
- Group Work and Workshops for Practical Application of Key Standard Aspects
Who Should Attend?
- Quality and Regulatory Affairs Teams
- Senior and Middle Management
- Software Developers
- Production and Engineering Teams
- Medical Device Consultants
Prerequisites: Participants are recommended to have prior knowledge of medical devices and quality management systems to maximize the benefit of the training.
Learning & Career Benefits
- Gain in-depth understanding of IEC 62304:2015 (Amendment 1) and IEC 82304-1 software standards
- Learn how to implement these standards effectively within your organization
- Acquire know-how for optimizing medical software development processes
- Engage in best practice exercises to deepen your practical understanding of the standards
Examination & Certification
The course concludes with an online open book examination
- Duration: 1 hour 30 minutes
- Passing Criteria: Minimum 70% overall
- Participants who pass will receive a TÜV SÜD South Asia Completion Certificate
- Those who do not pass will be awarded an Attendance Certificate
Get in touch with us to know more.
Business address
TÜV SÜD Bangladesh (Pvt.) Ltd.
Update Tower, Level- 12, 8 & 14, 01 Shahjalal Avenue, Sector-06, Uttara Model Town, Dhaka-1230, Bangladesh
Tel: +88 02 58954115, 58954120, Ext-119
Email: [email protected]
