A Real time health monitoring product required highly reliable IEC 62304 standard complaint software for FDA approval
Gadgeon developed embedded firmware and mobile app for real time ECG and respiration monitoring in accordance with medical standards required for making the product complaint for FDA
Followed IEC 62304 software life cycle process for development with all the mandatory documentation.
Multichannel ECG and Respiration data from the body-worn sensor is reliably transmitted over Wi-Fi to the Mobile App
Embedded firmware was developed with optimized code for maximum power saving so that it can operate on low power batteries.
Outcome and Benefits Delivered
The patch could work on coin cell batteries for multi day operation as the embedded biosensor firmware was written in highly efficient and power optimized way
Mobile app and user workflow was designed and developed in line with the requirements of medical practitioners
Highly accurate waveforms display in the App enabling better informed decisions for healthcare givers .
Real time alerting in the event of critical medical events
The Solution / System Description
Gadgeon developed medical complaint software by taking software development through all phases of IEC 62304
IEC 62304 – Medical software life cycle process to cover
SW risk management
SW configuration management
SW problem resolution
Architected the entire solution and provided the appropriate risk mitigation solution for developing the embedded firmware and mobile application.
This includes Requirement, Gathering & Analysis, Uses cases, Architecture development, identification of functional identification OTS for embedded firmware and mobile app and verification strategy. Risk analysis and Risk mitigation plans for software components was done.
Mobile app and user workflow was designed and developed in line with the requirements of medical applications
Thank you for choosing to be part of our community at Gadgeon Systems Inc ("Company", "we", "us", "our"). We are committed to protecting your personal information and your right to privacy. If you have any questions or concerns about this privacy notice, or our practices with regards to your personal information, please contact us at email@example.com.
When you visit our website www.gadgeon.com (the "Website"), and more generally, use any of our services (the "Services", which include the Website), we appreciate that you are trusting us with your personal information. We take your privacy very seriously. In this privacy notice, we seek to explain to you in the clearest way possible what information we collect, how we use it and what rights you have in relation to it. We hope you take some time to read through it carefully, as it is important. If there are any terms in this privacy notice that you do not agree with, please discontinue use of our Services immediately.
This privacy notice applies to all information collected through our Services (which, as described above, includes our Website), as well as, any related services, sales, marketing or events.
What information do we collect?
Personal information you disclose to us
In Short: We collect personal information that you provide to us.
We collect personal information that you voluntarily provide to us when you express an interest in obtaining information about us or our products and Services, when you participate in activities on the Website or otherwise when you contact us.
The personal information that we collect depends on the context of your interactions with us and the Website, the choices you make and the products and features you use. The personal information we collect may include the following:
Personal Information Provided by You. We collect names; phone numbers; email addresses; and other similar information.
All personal information that you provide to us must be true, complete and accurate, and you must notify us of any changes to such personal information.
How can you contact us about this notice?
If you have questions or comments about this notice, you may email us at firstname.lastname@example.org or by post to:
Gadgeon Systems Inc
881 Yosemite Way, Milpitas, CA 95035,
How can you review, update, or delete the data we collect from you?
Based on the applicable laws of your country, you may have the right to request access to the personal information we collect from you, change that information, or delete it in some circumstances. To request to review, update, or delete your personal information, please submit a request form by clicking here. We will respond to your request within 30 days.