Optiscan has well-established quality and compliance processes for complex development projects in clinical and pre-clinical applications. Our quality systems are flexible, allowing partner specific development plans to be created.
Our quality systems are;
- Certified to ISO 13485:2016, an international quality standard that demonstrates our ability to provide medical devices and services that consistently meet customer and regulatory requirements.
- In alignment with 21CFR820 and EU Medical device regulations.
Appendix 4G & Corporate Governance Statement released to ASX on 31 Aug 2022