Regulatory

Scarletred®Vision is an objective skin documentation and image analysis software platform. It is developed, registered and marketed by the Austrian Digital Health Company SCARLETRED in form of a CE class I medical device (the “Product”) and distributed at present via Software as a Service (SaaS) mainly to Biopharma-, Cosmetics-, Medical- and Insurance companies as well as Health Care Professionals.

The patented product is mobile, runs via App on smartphones and connects to SCARLETRED’s secured online platform, integrating remote data monitoring, skin image-analysis and customizable service tools. The product fulfils leading international industrial quality and regulatory standards according to ISO13485, a harmonized standard defining the requirements for a quality management system, where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The system complies with European General Data protection Regulation (GDPR), the US Health Insurance Portability and Accountability Act (HIPAA) and the Act on Protection of Personal Information (APP) in Japan.  It  and enables to introduce an ICH-GCP conform digital process flow.

Effective and secure technology.
Patented world wide

ISO 13485 Medical

This certificate asserts that our Quality Management System fulfills all regulatory requirements. Therefore, it is possible to use SCARLETRED®Vision in your product lifecycle without risking breaches in conformity with regulatory standards.

CE Class1

SCARLETRED®Vision is in accordance with the European medical device law. It harbors no risk for the security or health of patients. All claims have been proven to medical authorities.

Intellectual Patented Property

SCARLETRED®Vision has been patented in many different counties. This ensures that our software and skin patch technology can only be marketed by us and we can ensure a high- level quality of SCARLETRED®Vision.

GDPR Data Protection

SCARLETRED®Vision has sufficient procedures in place, to ensure data protection and security for each individual user.

ICH GCP Compliant

As a certified ICH GCP compliant product, SCARLETRED®Vision fulfills all ethical and scientific standards to ensure patient’s welfare according to the declaration of Helsinki.

HIPAA Compliance

The certified compliance to the Health Insurance and Accountability Act ensures that SCARLETRED®Vision fulfills the highest standards in data protection and security.

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Companion Analytics

If you want to use our product in one of your clinical trials, we can offer our software Scarletred®Vision as a Companion Analytics Software.

Every clinical trial has different requirements, different patient groups and different end points. In addition to being a powerful documentary tool, our software can also be used in the analytics. Use cases include automated scoring of the grade of erythema, comparison of the erythema development in placebo and treatment groups, comparison of the timing of occurrence and clearance of erythema, prediction on the course of erythema, and many more. We will adapt our software to your specific needs in parallel to the drug development process, so that the system is ready to use at the beginning of the phase III clinical trial

co-development of drug product

Pre clinical phase

-

Clinical phase

1

Clinical phase

2

Clinical phase

3

• Define requirements

• Develop prototype

• Test & Refine

• Validate

• Fully developed analytic support