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Yesterday, Verena Wieser successfully presented on the topic "Requirements Management: Building a Robust Framework for Secure Software" at MedConf 2024.🎉 Below are some valuable insights from the presentation: 📌A good requirements management is the base for the development of safe and secure medical device software. Many problems that occur with medical device software are the results of unclear and faulty requirements that led to misunderstandings by the involved stakeholders. ❌ 📌The EARS methodology provides a set of key words and simple rooms to depict requirements in a simple and understandable way in English language. 📌A term that is strongly related to requirements management is traceability. Its aim is to provide evidence from the initial idea to the delivered software. This includes traceability between system requirements, software requirement, risks, risk control measures, verification, and validation activities. 🔗 📌The obvious way to document this traceability is to create a trace matrix but this can get an exhaustive and error-prone activity. 📌It is more efficient to use the various tools that are available on the market to support requirement management. The choice of the right tool depends on the team and the established processes. Each tool has its advantages and disadvantages that need to be considered in software tool validation as required by ISO 13485 before productive use. 🛠️ 👉 For more insights, contact us for consultancy: info@lorit-consultancy.com 📧 #MedConf2024 #RequirementsManagement #ISO13485 #LoritConsultancy

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