Quality is always
our top priority
Adhering to our commitment to meeting highest standard and quality
We are constantly working and improving to ensure the highest degree of it. Meticuly’s Quality management system (QMS) is designed around our vision. In parallel with the quality of the products itself, we are consistently focusing on improving our services and team members. We aim to provide our crafted and highest-quality titanium products and services worldwide. The world at large is entitled to seize on top of the line medical devices.
01
Quality management system (QMS) certifications
Our QMS has been tested for safety, accuracy, and reliability under real-world conditions by a certified 3rd party laboratory. We consistently uphold customer expectations of quality, safety and performance. Our QMS is designed and implemented to comply with the internationally recognized standard for the medical device industry.
-
EN ISO 13485:2016
-
Medical Device Single Audit Program (MDSAP)
02
Regulatory approval certifications
Meticuly’s 3D printed Patient-specific implant solution especially crafted and designed for patients in need. With its unique features and mechanical properties, our product is certified by the global standard to ensure its safety, efficacy, and security.
-
U.S. Food and Drug Administration (US-FDA) clearance
-
Thai Food and Drug Administration (Thai FDA)
03
Material Certifications
From materials research, we select medical-grade titanium, Ti-6Al-4V, to fabricate 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.