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Usability documentation of a diagnostic software for IEC 62366-1 und FDA
Project duration: 2 years, 6 months
Brief description
Documentation and application of usability engineering to the concept and development of medical lab software according to international standard IEC 62366-1 and FDA law for medical devices.
Supplement
Analysis of user groups, use context and technical environment affected by new functionalities. Technical derivation of use errors and potential misuse. Adapting product requirements and effort estimations to planned use risk mitigations. Documentation of all use risk-related activities according to IEC 62366-1 International Standard – Medical Devices – Application of usability engineering to medical devices and FDA – Applying Human Factors and Usability Engineering to Medical Devices
IT project data
- Industries pharmaceutical industry
- Specialist tasks accessibility, documentation, FDA validation, laboratory, laboratory systems, medical devices, product design, quality assurance, Requirements Engineering, risk analysis, sample processing, Usability
- DP tasks customised software further development
- System environments Client/Server
- Procedure model Scrum
- Programming languages Microsoft Silverlight, Schema (XML)
- Development and test tool ASTM Simulator, MS Team Foundation Server TFS
- Middleware and frameworks HL7, Middleware for diagnostic lab instruments
Project period01.01.2016 - 30.06.2018
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