CERTIFICATIONS
Quality Management & Certifications
Mimetrik Solutions Limited operates a Quality Management System (QMS) certified to ISO 13485, the internationally recognised standard for medical device design, development, manufacture, and post-market activities.
In addition, Mimetrik participates in the Medical Device Single Audit Program (MDSAP), which enables a single regulatory audit to satisfy the quality system requirements of multiple jurisdictions, including the United States and Canada.
These certifications demonstrate that Mimetrik:
- Applies a risk-based approach throughout the product lifecycle
- Maintains design controls, verification, and validation processes
- Ensures traceability and documentation across development and production
- Operates post-market surveillance and vigilance systems
- Continuously improves product quality and regulatory compliance
Regulatory Status
Mimetrik systems are developed and controlled in line with applicable regulatory frameworks in:
- United Kingdom – UK Medical Devices Regulations 2002 (as amended), MHRA registration and UKCA/CE recognition
- European Union – EU Medical Device Regulation (MDR 2017/745), CE marking
- United States – FDA requirements under 21 CFR Part 820 (Quality System Regulation)
- Canada – Health Canada Medical Devices Regulations, with MDSAP certification required for licensing
ISO Standards for 3D Dental Scanners
While ISO 13485 governs the quality system, 3D dental scanners are also evaluated against ISO 12836 for specific performance and accuracy.
This standard defines how laboratory dental digitising systems must be tested and validated.
What ISO 12836 Tests
1. Accuracy (Trueness and Precision)
- Trueness: how close a scan is to the real object
- Precision: how consistent repeated scans are
- Typically assessed using calibrated reference models
2. Resolution & Detail Reproduction
- Ability to capture fine anatomical features (e.g. margins, occlusal surfaces)
- Critical for prosthesis fit
3. Full-Arch Performance
- Measurement of distortion across larger scan volumes
- Ensures accuracy is maintained over complete dental arches, not just small areas
4. Repeatability & Reproducibility
- Consistency across:
- Multiple scans
- Different operators
- Different devices
5. Data Integrity & Output
- Validation of exported 3D files (e.g. STL format)
- Ensures compatibility with downstream CAD/CAM systems
6. Environmental & Operational Conditions
- Performance under defined lighting and usage conditions
- Robustness of scanning process in real-world workflows
What This Means in Practice
For Mimetrik’s 3D scanning systems, compliance with ISO standards ensures:
- Reliable digital models for prosthesis manufacturing
- Consistent scan quality across users and environments
- Reduced need for remakes due to improved fit and accuracy
- Confidence that outputs integrate seamlessly into digital dental workflow
The accuracy of the scans produced by the Cubit360 were verified according to EN ISO 12836:2015.
- The demonstrated accuracy of the standard “inlay” test specimen was 1.3 (±1.1) µm.
- The demonstrated accuracy of the standard “bridge” test specimen was 1.9 (±6.4) µm.