Certified quality procedures for medical devices industry



Certified quality procedures in compliance to medical devices requirements

Valtecne has always put a lot of effort into the implementation of its own quality system. Quoting from Valtecne’s quality policy, “the success of the company and the satisfaction of the customers depend on the quality of supplied products”.

The first quality certification ISO:9001 dates back to 1997. In the following years, after entering highly demanding markets such as medical devices, the company has furtherly implemented its quality system with sectoral certifications.

Valtecne is certified in accordance with the UNI EN ISO 9001:2015, and it is certified for the ISO 13485:2016 medical devices quality management system. Furthermore, the facility is registered in the Food and Drug Administration (FDA), confirming its commitment to the safety of its products.


Quality control equipment

The company has at its disposal a wide spectrum of quality control equipment.

The most important assets are three-dimensional measuring machines (CMM – Coordinate Measuring Machine), mainly from Carl Zeiss AG. Valtecne’s quality technicians do have the skills to program CMMs so that the probe measures what the drawing requires.

Furthermore, the company is equipped with a complete set of precision control instruments such as altimeter, durometer, profilometer, calipers, gauges and so on.

ISO 13485:2016

Validation of processes

Valtecne has carried out the validation of its own processes according to the international medical devices standard ISO 13485.

The validation methodology is the one recommended by FDA, the American regulator, and it is based on three steps: IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).

The company has validated the following processes: machining, passivation, heat treatment, polishing, welding, bead blasting, marking, and cleaning. Moreover, Valtecne has established a set of internal procedures and instructions to make sure that operating processes are compliant with the requirements established in the validation system.