🛡️ Quality Assurance & Compliance
Trusted Quality at Hermann Meditech
At Hermann Meditech, 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 fosters innovation and efficiency through:
✔ Lean manufacturing
✔ CAPA systems
✔ Customer feedback loops