Quality and Certification

OptiScan have well-established, independently certified quality systems.

Quality Systems

OptiScan have well-established processes for complex development projects in both clinical and pre-clinical applications. Our quality systems are flexible, allowing partner specific development plans to be created.

OptiScan’s quality systems are;

  • Certified to ISO 13485:2016
  • In alignment with 21CFR820 and EU Medical device regulations