Our Compliance
From regulatory approvals to data security, OptimallyMe ensures your platform is compliant, safe, and scientifically robust.
ISO 27001 certified
Our information security management system is independently certified and continually improved.
UK GDPR compliant
Each client’s data is kept in its own isolated environment, with role-based access so people see only what their role needs.
Accredited laboratories
Tests are processed by UKAS-accredited ISO 15189 partner laboratories, the international standard for medical labs.
Regulated test kits
Collection kits are CE-IVD and UKCA marked, MHRA-registered and manufactured under ISO 13485.
Regulatory support
Whatever your product classification and target market may be, we support the full regulatory and compliance process, so your tests are ready to go to market.