Enfis firmly believes in using, maintaining and developing an effective Quality Management System (QMS). As such, it has achieved ISO 9001:2000 (General QMS requirements for medical devices).

The QMS is also designed to be compliant with the American regulatory requirements for medical devices (21 CFR 820).

The design and development process is key for getting the right product to market. For medical devices, the process is essential in order to satisfy the stringent requirements of Medical Device Directive. The design is based on the USA FDA design control guidance for medical devices.

The process includes full customer, market and regulatory input, as well as regular design reviews. Product verification and validation is also an integral part of the process.

The design and development process for medical devices is very robust and is considered best practice.

As part of our plan for continuous improvement, an Environmental scheme has been introduced. During March 2006, we achieved Level 3 of the Green Dragon Environmental Standard.