We are always committed to understanding and meeting the quality needs and expectations of all customers. Amedcon has a reputation for delivering quality product. We have established a comprehensive Quality Assurance System that allows our company to meet the requirements of ISO 13485 in design and manufacturing of medical and healthcare device products.

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Our Quality Statement:

  1. Quality is the responsibility of everyone in our company.
  2. Product safety and customer satisfaction are always our top priorities.
  3. Continuous improvement and training are essential in order to maintain our best quality products and services to our customers.

Our Quality System can ensure the entire design, development and production processes are tightly controlled, documented and traced which includes :

  1. Design validation and verification
  2. Process validation : DMFA, CPK and FMEA
  3. Confirmation of raw material
  4. Production monitoring
  5. Final inspection of the product

Our Certification:

  1. ISO 13485:2003
  2. FDA Registered
  3. CE Mark

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