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Home 9 Quality

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.


Validated processes

Our commitment to obtaining and maintaining ISO certifications is through rigorous and validated production processes. This ensures that each product meets the high quality standards required

Internal controls and annual audits

An effective quality management system ensures, through strict procedures and controls, that every process in FL Medical is constantly monitored and that any changes to it are promptly communicated to TÜV to ensure compliance.

Global recognition

TÜV certification is not only a confirmation of our quality, but also the expression of our ambition to represent a worldwide benchmark.
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