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
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 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” and 93/42/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 ISO 6717 In vitro diagnostic medical devices – Single-use containers for the collection of specimens from humans other than blood
EN ISO 6710 Single-use containers for human venous blood specimen collection
EN ISO 18113-1 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling)
New TÜV certification
A shared commitment to global excellence
What is behind this choice? TÜV is globally recognized for the attention to details. TÜV is not only one of the most prestigious notified bodies, but a recognized competence symbol. For FL Medical this choice is a tangible sign of the constant commitment to continuous improvement. We chose to obtain ISO 9001 and ISO 13485 certifications with such an authoritative notified body to respond to the increasingly high quality required by the market and to strongly emphasize our commitment and our distinctive position in the global panorama of in vitro diagnostic devices.
