Our Certifications
Every instrument forged at Mira Surgical is manufactured to meet rigorous international medical device standards and certified quality management systems.
Medical Devices QMS
Certified standard for medical device design, manufacturing, passivation, and international export with comprehensive traceability.
EU MDR 2017/745
Conformity for Class I and reusable Class Ir surgical and dental instruments compliant with European healthcare regulations.
21 CFR Part 820 (cGMP)
Compliance with FDA Quality System Regulations and Current Good Manufacturing Practices for international distribution.
Quality Management System
Comprehensive organizational and production quality management ensuring continuous improvement and client satisfaction.
Need Official Copies of Our Certificates?
We provide verified copies of our ISO 13485 certificates and declarations of conformity for hospital purchasing departments and international distributors.