Quality Assurance & Compliance
Trusted Quality at Hermann Meditech Ltd.
At Hermann Meditech Ltd. we specialize in crafting high-precision surgical and dental instruments that meet global healthcare standards. Our commitment to quality, safety, and regulatory compliance drives every step of our process—from raw materials to the final product in your hands.
Our Quality Commitment
ISO 13485 – Medical Devices QMS- FDA 21 CFR Part 820 – Quality System Regulation
- EU MDR 2017/745 – Medical Device Regulation
- CE Certified Instruments
- Full traceability and post-market surveillance
Quality Control Measures
1. Material Inspection
Verified raw materials with certificates (CoC, CoA) Only surgical-grade stainless steel and tested alloys
2. In-Process Inspection
Dimensional checks using calibrated tools Surface finishing, edge sharpness, and tolerance control
3. Final Product Inspection
100% visual and functional testing Sharpness, alignment, corrosion, and finish inspections
4. Sterilization & Packaging
Ultrasonic cleaning and sterilization validation Sterile barrier systems and UDI labeling
Equipment & Calibration
All inspection tools and manufacturing equipment are calibrated regularly to ensure accuracy. Preventive maintenance and calibration logs are strictly maintained.
Documentation & Compliance
Full lot/batch traceability Compliance with MDR/FDA standards Regular audits and continuous improvement initiatives
Trained Experts
Our team undergoes regular training in quality control, safety standards, and process improvement to maintain excellence.
Continuous Improvement
Hermann Meditech Ltd. fosters innovation and efficiency through: Lean manufacturing CAPA systems Customer feedback loops
Certifications & Downloads