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 Im 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 fulfills 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 enables the introduction of an ICH-GCP conform digital process flow.
Effective and secure technology.
Patented world wide
ISO 13485 QMS Certified
SCARLETRED maintains a Quality Management System certified to ISO 13485:2016+A11:2021 by an accredited certification body, covering the design, development, and lifecycle management of medical devices.
CE Marked
Class Im Certified
Class IIa Ready
SCARLETRED®Vision is CE marked in accordance withthe European medical device law. SCARLETRED®Vision is classified as a Class Immedical device in accordance with Directive 93/42/EEC (MDD). For Class IIa, conformity assessment is in-progress with the Notified body.
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.
EU GDPR Compliant
SCARLETRED®Vision is designed in compliance with the (Europe) General Data Protection Regulation (GDPR) and incorporates data protection by design and by default, robust security controls, and clear data governance processes.
ICH GCP Compliant
SCARLETRED®Vision is designed to support clinical investigations conducted in compliance with ICH E6 Good Clinical Practice (GCP) and applicable regulatory requirements.
US HIPAA Compliance
SCARLETRED®Vision implements security and privacy controls aligned with the requirements of the (United States of America) Health Insurance Portability and Accountability Act (HIPAA) to support the protection of health information.
ISO 27001 Compliant
SCARLETRED®Vision is compliant with Information Security Management System based on ISO/IEC 27001 standard.
MD Compliance
As per the intended use, SCARLETRED®Vision is Software as a Medical device
CE Class Im
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.
EUAI Act Compliant
Scarletred continuously monitors regulatory developments, including the EU Artificial Intelligence Act. Where applicable, our AI-driven technologies are assessed to ensure alignment with the Act’s requirements, including risk classification, transparency, data governance, and human oversight obligations.
DPDP, APPI, PIPEDACompliant
Scarletred implements data protection measures designed to align with applicable data protection and privacy regulations, including the Digital Personal Data Protection Act (India), the Act on the Protection of Personal Information (Japan), and the Personal Information Protection and Electronic Documents Act (Canada), where applicable.
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
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Clinical phase
1
Clinical phase
2
Clinical phase
3
• Define requirements
• Develop prototype
• Test & Refine
• Validate
• Fully developed analytic support