At DermaVision, we are committed to adhering to the highest standards of regulatory compliance to ensure the accuracy, security, and ethical use of our forensic imaging technology:
FDA Approval: DermaVision qualifies as a Class I device due to its minimal risk to users. We are pursuing FDA approval via the de novo pathway to classify our solution as a Class I medical device, further validating its safety and efficacy.
Clinical Study Approval: Our clinical study has received approval from the Institutional Review Board (IRB), confirming that our study protocol complies with rigorous rules and standards for ethical research conduct.
Certifications and Training: All DermaVision team members are compliant with the Collaborative Institutional Training Initiative (CITI) and UC Learning Center (UCLC) standards, and have received relevant certifications in areas such as human research for biomedical investigators and the Health Insurance Portability and Accountability Act (HIPAA).
By prioritizing regulatory compliance, we ensure that our technology meets the highest standards of safety, efficacy, and ethical practice, instilling confidence in our customers and partners.
