nehalmahajan55
Starting to get Involved
I have prepared a design input for a medical device which we are currently working on. But I am not sure if i am getting this right. I have attached it below hoping if someone could see it and guide me for any necessary changes
| Design Input ID | Source | Description | Rationale | Acceptance Criteria | Relevant Stantards/Regulations |
| DI-001 | User Need Requirements | The need for a portable ECG monitoring device for remote monitoring of cardiac activity | To address the increasing demand for convenient and accessible cardiac monitoring solutions, especially for patients with cardiac conditions or at risk of arrhythmias | The device must be portable, lightweight, and easy to use. It should provide accurate ECG measurements and support wireless data transmission for remote monitoring. | FDA 510(k) requirements, ISO 13485 |
| DI-002 | Regulatory Standards | Compliance with FDA regulations for medical devices and wireless communication standards | To ensure the device meets regulatory requirements for safety, performance, and interoperability. | The device must comply with FDA guidelines for Class II medical devices and Medical Device Directive and In Vitro Diagnostic Medical Devices Directive in the European Union, where it is classified as a Class IIb medical device, including validation of wireless communication security and performance. It should also adhere to relevant wireless communication standards such as Bluetooth Low Energy (BLE). | FDA 21 CFR Part 820, IEC 62304, ISO 14971, Bluetooth SIG standards |
| DI-003 | Clinical Requirements | Accurate detection of arrhythmias and abnormal ECG patterns | To enable early detection and diagnosis of cardiac abnormalities, including arrhythmias, to facilitate timely medical intervention. | The device must have high sensitivity and specificity in detecting arrhythmia | |
| DI-004 | Technology Capabilities | Wireless signal transmission capabilities and integration with mobile applications for AI-based analysis. | To enable remote monitoring and analysis of ECG data using mobile devices equipped with AI algorithms. | The device must support wireless communication protocols such as Bluetooth or Wi-Fi for seamless data transmission to mobile applications. It should be compatible with iOS and Android platforms and allow integration with AI algorithms for real-time arrhythmia detection and analysis. | |
| DI-005 | Battery Life | Long battery life to support continuous monitoring and extended useage | To ensure uninterrupted monitoring and usability without frequent recharging. | The device should have a battery life of at least ?? hours under typical usage conditions. It should also provide low-battery alerts to users. | |
| DI-006 | Data Security and Privacy | Secure storage and transmission of patient data to protect confidentiality and comply with privacy regulations. | To safeguard sensitive patient information and maintain compliance with data protection laws. | The device must implement encryption algorithms and secure data transfer protocols to protect patient data during transmission. It should comply with HIPAA regulations and other applicable privacy laws. | HIPAA |
