There are no prerequisites for attending this training
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.
This training is tailored to an iterative / agile way of software development
The training includes several practical examples on efficient software documentation.
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.
Liever deze opleiding bedrijfsintern volgen? Op maat van de organisatie en voordelig vanaf 5 deelnemers.
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