User Requiremnts
User Requiremnts
Customizable Notifications
Implement machine learning algorithms to analyze collected data for identifying patterns, trends, and potential triggers of m
disorder symptoms, aiding in personalized care planning.
Incorporate validated scales and algorithms to assess the severity of symptoms automatically, providing users and healthcare
with standardized assessments.
Integrate a feature allowing users to provide immediate feedback on their symptom status and the impact of treatments or
enriching data for more personalized care.
In addition to FDA regulations, comply with international standards such as ISO 13485 for medical devices, ISO 14971 fo
management, and IEC 62304 for medical device software lifecycle processes.
Establish mechanisms for ongoing post-market surveillance to monitor the safety and effectiveness of the device, including a
adverse event reporting in compliance with FDA requirements.
Enable users to customize notifications for medication reminders, activity suggestions, or symptom diary entries to enhance e
and adherence to care plans.
Provide interactive educational content on movement disorders, treatment options, and lifestyle tips within the app, helpin
better understand and manage their condition.
Ensure compatibility and integration capabilities with other health monitoring devices (e.g., fitness trackers, smart scales) to
more comprehensive view of the user's health status.
Utilize cloud-based solutions for data storage and management, facilitating real-time data access, backup, and recovery whil
scalability and security.
Provide on-demand support and options for virtual consultations with healthcare providers through the app, enhancing acce
and support for users.
Offer a continuous education program for healthcare providers on the latest developments in movement disorder manageme
use of the device, ensuring they can provide the best care and advice to their patients.
Use adaptive algorithms that learn from the individual's data over time to provide personalized insights and recommenda
managing symptoms more effectively.
Optimize data transmission methods to be energy-efficient, reducing the impact on device and smartphone battery life while e
continuous collection and transmission of data.