Pristine 5.0

The Pristine 5.0 app allows established Remidio customers to easily and efficiently capture images of the retina with the Remidio Pristine 5.0. The app is fully integrated with a cloud platform that allows users for easily creating patient exams & uploading posterior & anterior images.
With offline use capabilities users can capture images, create reports and upload them anytime. The Remidio Pristine 5.0 is a retinal camera specifically engineered for capturing high-quality images of the human retina. While the App is sesigned to integrate seamlessly with Apple iPads, it offers user-friendly navigation and enhances the efficiency of patient counselling for healthcare professionals.

Compliance Statement with Guideline 1.4.1 - Safety - Physical Harm
Application: Remidio Pristine 5.0 App
Remidio’s app connects to external medical hardware i.e., Remidio pristine 5.0 to enable the user to view, save, archive, edit, retrieve images captured by Remidio pristine 5.0, the software itself does not qualify as a medical device by definition or intended use. This makes the app, a low-risk software which does not draw attention to any of the regulatory approval nor there is a provision for a regulatory application process.
We hereby declare that the distribution of Remidio’s app with external medical hardware i.e., Remidio pristine 5.0 will be restricted by availability and use to the Indian states only. Remidio pristine 5.0 is approved by Central Drugs Standard Control Organisation, Government of India to manufacture for sale and distribution (Licence Number: MFG/MD/2023/000841) in India.

The output of the app is not sufficient to make a clinical or a medical decision. the users must consult a Physician or a specialist or a healthcare provider to conclude a medical or a clinical decision.
Furthermore, it is crucial to highlight that our app incorporates stringent access control measures to safeguard user’s privacy. Only authorized individuals are granted access to the app through specific login credential and password. The authorization process involves a series of steps, including user input, authentication requests, and verification against our secure system. We remain committed to upholding the highest standards of compliance and security in all aspects of our app's functionality
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Sincerely,
For Remidio Innovative Solutions Pvt. Ltd