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日期:2025-01-09 05:22

Question 2 [20 marks]: Identify all the stakeholders of your project. In less that 400 words, describe how each of them will engage with the software life cycle steps as part of the development of your product. You can refer to your selected process model should it help arguing your answer.

Question 3 [15 marks]: As you are developing a software as a medical device, you need to identify the classification of your product. In less that 150 words, indicate the classification and justify your answer. To answer this question, you can refer to the UK regulation according to the Medical Device Directive 93/42/EEC or the EU regulation MDR 2017/745.

Question 5 [25 marks]: As part of your certification process, you will need to verify and validate your product. Detail, in less than 200 words, how your intent to verify your tool and what are the objectives of verification. In another 200 words max, describe how you could validate your tool.

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