SCARLETRED is proud to announce that it has achieved ISO/IEC 27001:2022 certification, the international standard for Information Security Management Systems. The certification follows a formal audit by an independent notified body, which verified that SCARLETRED's approach to identifying, assessing, and treating information security risks meets the international standard’s requirements.

A new benchmark for information security

The ISO/IEC 27001:2022 certification confirms that SCARLETRED operates globally with a structured ISMS built around 93 security controls spanning four areas: organizational, people, physical, and technological security. This includes access control, encryption, incident response, business continuity, supplier security, and physical and data center security.  

The audit also verified that SCARLETRED's security policies and procedures are not only documented but followed in practice, supported by a functioning internal audit and management review process, and backed by top-management commitment and accountability for information security.

A trust signal for partners

Pharma, CRO, and clinical trial sponsors increasingly require ISO 27001 as part of vendor qualification, and this certification directly strengthens SCARLETRED's position in vendor audits. It provides externally verified assurance of integrity and availability of patient images and clinical trial data, complementing the regulatory requirements SCARLETRED already meets at local and international level.

For SCARLETRED's partners, the certification also reduces friction in procurement: a common blocker in enterprise and pharma buying processes is removed, since independent validation from an accredited notified body carries more weight than self-assessment. ISO 27001:2022 certification is a genuine differentiator in the medical AI and clinical skin imaging field.

“Information security is the foundation for how we protect patient-, clinical- and customer data every single day. Achieving ISO/IEC 27001:2022 is an important company milestone. It is also an important confirmation that the system and discipline we have built around data collection and protection meet the highest international standard”, says Dr. Harald Schnidar, CEO & Founder of SCARLETRED.

Strengthening a strong regulatory foundation

The ISO/IEC 27001:2022 certification adds to SCARLETRED's existing regulatory credentials as a CE-certified Software as a Medical Device (SaMD), reinforcing the company's commitment to data protection as it continues to scale Scarletred®Vision, powered by ARORA®AI, with industry and clinical trial partners worldwide.

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