TechFile Factory at NSF International

NSF International (formerly PROSYSTEM) offers its customers an extended technical documentation service in accordance with Regulation (EU) 2017/745, Annex I, II and III.

Optimize Documentation Completion Cost and Time

The aim of this extended service is cost- and time-optimized preparation and maintenance of technical documentation compliant with the Regulation (EU) 2017/745 on medical devices using proven methods and documentation pro-cesses. In addition, we will optimize existing concepts and processes, provide enough competent resources and, if necessary, establish a new infrastructure, tools and processes.

Pool of Qualified Resources

Our global organization provides a pool of expertise and human resources . In addition, we have significantly strengthened our Hamburg location by adding office space at the Berliner Tor Center. Part of this expansion is being used to establish the expanded TechFile Factory service.

To do so, we created the following framework:

  • A well-established team of permanent employees takes care of the evaluation, creation and maintenance of your technical documentation.
  • The infrastructure enables active communication within our office (large office space with individual and team workplaces) and with the custom-er (customer involvement during meetings on our premises), as well as equipment for web and telephone conferences and appropriate con-ference rooms.
  • We have a DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016 certified quality management system. Proven tools, methods and processes are used to ensure optimal processing of the technical documentation.
  • The team identifies all necessary data and customer documentation in close cooperation with the customer.
  • All data and documents provided are recorded, processed and archived in a secure IT infrastructure (in accordance with ISO 27001:2013).
  • The data and documents provided are evaluated against regulatory re-quirements. Subsequently, a strategy for revising individual medical de-vices or generic medical product groups will be developed.
  • An expert team develops risk management, usability, clinical evaluation and post-market surveillance activities specific to your product, includ-ing the customer and customer processes.
  • The result is user-friendly, searchable and clearly structured technical documentation that can be used to demonstrate compliance with Regu-lation (EU) 2017/745 on medical devices and other markets regulations.

We aim both to prepare technical documentation for your medical devices / generic product groups and to provide maximum support through the assump-tion of all possible activities.
This allows you time to focus on the implementation of other requirements of the regulation and other regulatory requirements with existing internal re-sources.
We offer a decisive advantage, since you can add resources and new services as new tasks and bottlenecks arise.

For more info on “TechFile” or for a quotation please contact us.