For this coursework, answer the following questions in a single document and submit your answers as a PDF.

You have developed a prototype software that given demographic information about a patient (age, gender) and a chest Xray, and using machine learning, is able to predict whether a patient is at risk of developing a variety of pathologies. The findings are stored within an automatically generated report. During your preliminary analysis, your prototype obtained a 90% ROC AUC, that is comparable with the performance of an expert clinician.

You now want to productise your prototype and received sufficient investment to do it. You can hire software developers. You also have sufficient fundings to obtain time from clinical expert, regulator expert and conformity assessment to allow procurement by the hospital for its intended use within the hospital.

You would like your product to be deployed with Guy’s and St Thomas’ Hospital, where it will connect to the EHR and the PACS, to retrieve the demographic and scanner data respectively. The generated report will be pushed to be store within CRIS. The Fast Healthcare Interoperability Resources standard will be used to communicate with the EHR, the DICOM protocol will be used to communicate with the PACS, and your product will interact with RIS via a dedicated API.

Question 1 [20 marks]: Identify the different high-level components that will constitute your software. These components will be used to implement an object-oriented based architecture. In less than 400 words, describe your overall architecture (What are the components? How do they interact?) and each component in more details (what do they encapsulate? What are their functionalities?). Use a diagram to illustrate your answer.

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 4 [20 marks]: For your medical device certification, a risk management document will have to be submitted. It should include a risk management table (risk table). Complete such a table for all aspects related to your software. Your table could include up to 20 rows.

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.