IEC 62304 - Standard | Medical Device Software – Software life cycle processes
One-day training
There are no prerequisites for attending this training
Risk-based classification and specifies process requirements
IEC 62304 proposed a risk-based classification of medical device software and specifies process requirements for each class. The IEC62304 standard provides a framework of life cycle processes necessary for the safe design and maintenance of medical device software. Compliance with this standard is expected by most regulators.
Software is often an integral part of medical device technology. In addition, may medical devices are software only. Establishing the safety and effectiveness of a medical device software requires knowledge of what the software is intended to do and demonstration that the use of the software does not lead to any unacceptable risks.
Resultaten
Results
- Understand all clauses of IEC62304
- Be able to use IEC62304 during medical device software development
- Understand how to prepare minimal but sufficient documentation
Programma
This training covers the following topics
This training is tailored to an iterative / agile way of software development
- Background of IEC 62304
- Classification and relation to risk management ISO 14971 and IEC/TR 80002-1
- Software development planning
- Software requirements analysis
- Software design, testing and release
- Software maintenance
- Configuration and change management
- Software risk management
- Practical documentation examples
- Using IEC62304 with Agile software development
The training includes several practical examples on efficient software documentation.
Doelgroep
SME’s and SE’s developing software as a medical device or software as part of a medical device. Software development engineers, Product development engineers, Product Managers, Development Mangers, Product Owners, Quality managers / engineers.
Jouw coaches
Praktische informatie
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