Mehr Infos

Whitepaper: Summative Evaluation/ Human Factors Validation using the example of Healthyfy

Author: Benjamin Franz

Reading time:

May 2024

We are pleased to present our latest white paper, which dives deep into the world of summative evaluation and human factors validation. This comprehensive document provides you with valuable insights into the implementation and process of this important evaluation method, illustrated by our example product Healthyfy.

 

What can you expect from our white paper?

  • Valuable practical tips. We guide you through the evaluation process of our sample product Healthyfy and show how the developers have successfully implemented these methods.
  • In-depth insights into the implementation and process of summative evaluation/human factors validation.

 

Who is this whitepaper for?

Our white paper is aimed at

  • Medical device developers
  • Professionally interested parties
  • Decision-makers
  • Professionals and newcomers

 

Download now and benefit

Download our white paper and find out how summative evaluation and human factors validation can help you in a specific case. We are convinced that you will gain valuable insights that will help you to successfully bring your products through summative evaluation/human factors validation.

0 / 5 (0)

Subscribe for our newsletter

E-Mail *
This field is hidden when viewing the form
This field is for validation purposes and should be left unchanged.

Related Posts

Human Factors Study: 9 Best Practices

Conducting a successful Human Factors Study is critical for medical device or IVD manufacturers who want to get their product approved according to FDA requirements. But in addition to regulatory...

read more
How can you meet MDR requirements without usability engineering?

To prove that you meet all MDR requirements regarding usability, you need a complete Usability Engineering File. Under certain circumstances, your product could use the abbreviated UOUP process of IEC 62366-1 for this purpose. If your product does not qualify for this, there is the possibility to argue on the basis of the Post Market Surveillance data of your (or a similar) medical device and to prove with an appropriate rationale that your product does not pose any unacceptable risks by its use. However, the latter may lead to unwanted discussions. A summative usability evaluation is often the safer way to go.

read more