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Regulatory Affairs
IVDR Usability Studies: A PeploBio Perspective

The In Vitro Diagnostic Medical Devices Regulation (IVDR) is a new European regulation that came into effect in May 2022. The IVDR places a strong emphasis on usability and requires IVD manufacturers to conduct usability studies to demonstrate that their devices are easy to use and safe.

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By
Jack Purvis
Published on
July 12, 2023
Updated on
June 14, 2023
Table of Contents

PeploBio is a CRO company that specialiases in conducting usability studies for IVD devices. We have a team of experienced personnel who can help you to design, conduct, and report on a usability study that meets the IVDR's requirements.

We understand that conducting a usability study can be a complex and challenging undertaking. That's why we offer a comprehensive service that includes everything you needneeded to receive accreditation get the job done, from study design, documentation, sample testing and to data analysis.

Our team will work with you to understand your specific needs and goals for the study. We will then develop a study plan that is tailored to your device and your target audience.

Once the study is underway, our team will collect data and analyze it to identify any usability problems with your device. We will then work with you to develop recommendations for how to improve the usability of your device.

At PeploBio, we are committed to helping IVD manufacturers bring safe and effective devices to market. We believe that usability studies are an essential part of this process.

If you are an IVD manufacturer, we encourage you to contact us to learn more about how we can help you with your IVDR usability study.

Here are some of the benefits of working with PeploBio for your IVDR usability study:

  • We have a team of experienced personnel who can help you to design, conduct, and report on a study that meets the IVDR's requirements.
  • We offer a comprehensive service that includes everything you need to get the job done, from study design to data analysis.
  • We are committed to helping IVD manufacturers bring safe and effective devices to market.

If you are interested in learning more about how PeploBio can help you with your IVDR usability study, please contact us today.

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