Documentation

Use-Lab has experience in the creation and evaluation of complete usability documentation, including Use Scenarios, Use Specifications or complete Usability Engineering Files. Just ask us - we check your existing documents or create your documentation in close consultation with you from scratch. We consider the relevant laws and standards such as MDR, IEC 62366, ISO 14971 and ISO 13485.

With more than 15 years of experience in the field of approval of medical devices and documentation of the associated processes as well as active participation in numerous national and international standardization committees and working groups, Use-Lab is a competent partner for the preparation of approval-relevant documents.

Of course, we discuss the individual requirements and the international target markets with each customer in advance. We then create all documents accompanying the development, such as the specification documents or evaluation plans and reports in a standard-compliant manner, so that they can be linked directly to the usability engineering file. In addition, we will also be happy to prepare the Usability Engineering File or the Human Factors Evaluation Report for the FDA or support you in preparing the Risk Management File, the design documentation or the final product file.

Our internal checklist helps us to document the iterative process, assign tasks and give you feedback on the current status at any time.

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Contact us, we will be happy to advise you individually in order to find an effective but also efficient way to a successful documentation.

Instructions for use

The instructions for use and other information products are by definition part of the user interface of a medical device. Accordingly, like the medical device itself, they are subject to the requirements of the usability engineering process. Frequently, however, the specific requirements are not known to the author of the instructions for use.

Since the current regulations and standards for medical devices have further shifted the focus to the information for use, special attention must be paid to the preparation and evaluation of these documents.

A user manual that is both correct in content and user-friendly has a positive influence on the safe operation of the medical product as well as on the user experience.

The essential points to consider when creating a user-friendly manual are the following:

  • Target group analysis
  • Short, simple and understandable sentences
  • Avoidance of technical and uncommon words
  • Logical structure
  • Chronological description of the action steps
  • Active formulations
  • Balanced picture-text ratio
  • Clear layout

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Use-Lab has experience in the creation and evaluation of user information taking into account the regulatory requirements for medical devices, such as the IEC 62366 series, the Medical Device Ordinance or the IEC 82079 series. Our cooperation in the advisory board Norms and Law of tekom, the Society for Technical Documentation, we are always up-to-date as far as the current requirements are concerned.

We evaluate the documentation at an early stage on the basis of our internal checklist and involve the user in the evaluation phases accompanying the development. We cooperate closely with our customers' technical editors and support their objective of target group-oriented and comprehensible user information.

  Thore Reitz or Torsten Gruchmann

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