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Instructions for Use and Labelling

Accompanying documentation and labelling for medical devices includes labels, Instructions for Use, Quick Guide, technical description, installation manual and training material

Technolution’s specialists can assist you in creating and evaluating accompanying documentation that is easy to read, supports the intended use of your device and fulfills the regulatory requirements.

 

Our specialists are experienced in writing, illustrating, designing and evaluating i.e. Instructions for Use, Quick Guides and labels. They can assist you in all phases of the development process, specifically with writing content, making informative illustrations, layout and specifying regulatory labelling requirements (i.e. MDR, DS/EN 1041, ISO 15223-1, 60601-1 and product specific standards).

 

In addition to this, Technolution can perform both analytical and empirical evaluations of the accompanying documentation for your device and help you determine if training is required for the safe use of your device.

 

When you work with Technolution, you get the competencies and experience of our entire organization. We draw upon each other’s knowledge and the rest of our specialists are available for sparring and consulting if needed in a project. Furthermore, Technolution has inhouse facilities for testing, building and designing products in our laboratory and prototyping workshop.

 

How our clients rate us

3.8/4.0

Quality of work

3.9/4.0

Overall satisfaction

4.0/4.0

Compliance with deadlines

3.9/4.0

Collaboration

Jens Thor Hansen

R&D Manager / Ambu

Technolution has been a key player in creating a product optimized for uses.

Ole Jakobsen

Owner / Axlab

Technolution’s broad know-how has meant that we have a well proven product ready for the market.

Our Capabilities

  • User Research and Use specification
  • Usability Engineering strategy and planning
  • Integration with Design Control and Risk Management
  • Task Analysis and Use error risk analysis
  • Summative evaluation (Human Factors Validation testing)
  • Human Factors documentation and reporting
  • Usability Engineering training and courses

Let's have a look at your next usability engineering project. Reach out to

Jon Storm Madsen ‧ head of usability engineering

Give Jon a call    or   Drop him a line