Hamburg, 31st March 2021, Janine Budinger

We are pleased to announce that NSF PROSYSTEM TechFile Factory has implemented quality management for the „Assessment, preparation and maintenance of technical documentation of medical devices including accompanying regulatory services“ and has been successfully certified according to EN ISO 13485:2016.
The new Annexes II and III of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on In-Vitro Diagnostica, provide detailed technical documentation requirements for all medical devices.
It is critical to update existing medical device technical documentation to meet the new general safety and performance requirements of the MDR and IVDR.
Due to the high resource requirements for evaluating existing files and then closing gaps, we have developed a flexible and efficient approach. Our TECHFILE team performs an in-depth assessment of MDD or IVD compliant technical documentation, identifies gaps, and provides recommendations to close those gaps. The entire process is supported by our cross-functional team of experts to ensure high quality results.

Our team is also in close contact with notified bodies and regulatory authorities through project work and networking activities, such as workshops and symposia. The result of our service(s) is easy-to-understand, searchable and clearly structured technical documentation for compliance with the Medical Devices Regulation (including for in vitro diagnostic devices) and for acceptance in markets worldwide.