We offer customised advice on the preparation and/or maintenance of technical documentation for medical devices or IVDs in accordance with the requirements of the Medical Devices Regulation or the IVD Regulation.
In cooperation with the Company’s staff, we will prepare the different sections of the documentation as required by Annex II of the applicable Regulation, reorganising the available data and information in an orderly, clear and, if possible, indisputable manner.
We will ensure, as required by the Regulation, that the resulting documentation is easily accessible, so that it can be more easily updated by the company personnel responsible for maintaining it, and more easily checked by Notified Bodies and Competent Authorities.
