Structure¶

1.Requirement Gathering¶

1.1 Stakeholders¶

Identify who will use or benefit from your app:

• Patients with epilepsy
• Caregivers / family
• Doctors / neurologists

Figure 3: App Users/Operators

1.2 Functional Requirements¶

What the App should do???

a).User registration and Login
Create your private account and sign in securely to keep all your personal health information safe.

b).Patient Profile Management
A simple place to save your basic info, like your type of epilepsy and your doctor’s contact details.

c).Seizure Monitoring
Easily record when a seizure happens, how long it lasted, and what might have caused it.

d).Mood Monitoring
A quick daily check-in to track how you’re feeling, helping you and your doctor see if your mood is linked to your seizures or meds.

e).Medication Diary
Set reminders to take your pills on time and keep a log so you know you’ve stayed on track.

f).Telehealth Consultation
Talk to a doctor through a private video call right inside the app, saving a trip to the clinic.

g).Alert ang Emergency Support
A quick way to notify your family or emergency services and share your location if you need help fast.

h).Reports
Automatically turn your logs into a simple summary that you can show your doctor during your next visit.

Figure 4: Key Features

1.3 Regulatory Requirements¶

Since the App deals with the patient health and diagnosis it is classified as SaMD software as Medical Device and has to follow the standards

• EU Medical Device Regulation (MDR 2017/745)
• GDPR (General Data Protection Regulation)
• IEC 62366-1 — Usability Engineering for Medical Devices
• IEC 62304 – Medical Device Software Lifecycle
• ISO 14971 – Risk Management
• IEC 82304-1 – Health Software Product Safety
• ISO 13485 – Quality Management System

Figure 5: Regulatory Requirments

Final Features and Specification¶

Use Cases¶

Figure: Usecase

Activity Diagrams¶