To achieve our goals, the Meticuly team is committed to providing the following initiatives:
- To innovative, world-class quality products conforming to customer’s requirements.
- To deliver our products and services within good time.
- To uphold a professional, confidential and honest service through a high level of business ethics.
- Adhere to related laws and regulations, with continuous improvements and an effective QMS.
OUR CORE VALUES
OUR INTERNATIONAL CERTIFICATIONS
Meticuly’s Quality Management System (QMS) is designed and implemented to comply with ISO 13485:2016. Our system has been tested for safety, accuracy, and reliability under real-world conditions by a certified 3rd party laboratory. A specially designed factory with controlled areas and clean rooms (class 10,000) has been certified by the Thai-FDA.
ROAD MAP FOR STANDARDS AND HEALTH CARE LISTINGS
- Thai FDA Approval for Manufacturing of Medical Devices
- IRB Approved for Clinical Trial (GCP) for Bone Replacement
- Certified for ISO13485
- Thai GMP (Good Manufacturing Practice)
- Thai Innovation List
- USFDA QSR system and product registration
We use medical-grade titanium, Ti-6Al-4V, to make our products. The raw material is CE Mark certified for medical use. In addition, other key instruments and components are also compliant with the highest medical standards.
CE Mark Certified Material