FL Medical quality assurance

FL Medical quality assurance

FL Medical always wants to be recognized as a quality leader in the field of plastic laboratory products. Over the years, FL Medical, in order to continue to be entitled to this appellation, had to adapt their control systems to the continuous evolution and growth of the technology and the production.

This has undoubtedly led to considerable efforts that, through thirty years of consolidated know-how, as laboratory equipment manufacturer, have always resulted in the direct feedback of customers.

Quality Management System

Our Quality Management System is certified in compliance with the following standards:

EN ISO 9001 “Quality Management Systems – Requirements”

EN ISO 13485 “Medical Devices – Quality Management Systems – Requirements”

Harmonized standards

The harmonized standards relating to European directives 98/79/EEC “In vitro diagnostic medical devices” and93/42/EEC “Medical devices” are applied, for example:

EN 556-1 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”

EN 15223 “Graphical symbols for use in the labelling of medical devices”

EN ISO 14971 “Medical devices – Application of risk management to medical devices”

EN 14254 In vitro diagnostic medical devices – Single-use receptacles for the collection of specimens, other than blood, from humans

EN 14820 Single-use containers for human venous blood specimen collection

EN ISO 18113-1 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling)