Quality Management System
ISO13485:2016
The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. As such we strictly adhere to our quality system to ensure we consistently design, develop and produce the medical devices with regularized guideline.
Quality Assurance at Design Stage
Design guarantee is paramount. We consider every possible risk in the design phase to ensure product quality, safety and reliability.
Quality Verification and Validation at Development stage
Test plans and inspection criteria are set to verify and validate the product quality throughout the whole development stage.
Manufacturing Environment Control
In house control on the temperature, relative humidity, pressure, particle and bioburden in all assembly clean rooms.
Supplier Control
- Periodical supplier audit and performance evaluation.
- Incoming control on all materials or components from suppliers.
Production Quality Control
- In-process and outgoing quality control by according to preset criteria.
- Product traceability on every production lot.
- In house laboratory for monitoring of materials, assembly environment and product quality.