Enfis firmly believes in using, maintaining and developing an effective Quality Management System. (QMS)

As such, it has achieved accreditation to...
ISO 9001:2000
(General QMS requirements) &

ISO 13485:2003
(QMS requirements for medical devices in August 2004).

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 and is compliant with the requirements of 21 CFR 820. The process includes full customer, market and regulatory input, as well as regular design reviews. Product verification and validation is also an important part of the process.

The design and development process for medical devices is very robust and is considered best practice. Because of this, the process is used to design and develop all products.

In addition, Enfis understands the regulatory requirements for the design, manufacture and supply of LED systems across a wide range of industries including industrial, agri-foods, lighting and consumer markets.

Click here to view the ISO 9001 & 13485 Certificate