Thanks to the ISO 13485:2012 certification LFM is allowed to develop, manufacture and market Medical Devices of all the three different classes:
- Class I
- Class II
- Class III
The medical devices are either manufactured on site or, in some cases, outsourced to qualified and controlled third parties: also in this cases LFM still keeps the responsibility as the producer.
Companies interested in making use of LFM expertise in this field are very welcome and may directly contact LFM in order to receive more information and evaluate a possible collaboration. Usually LFM carries out the activities necessary to create the dossier as well as all the procedures required to achieve the CE mark: once the certification of the medical device has been received, it is then possible to proceed with the manufacturing of the product and its market launch.