Scientific validity reports based on in-depth literature review

What is Scientific Validity?

Scientific validity is concerned with the association of the analyte of a device with one or more clinical conditions or physiological states (Regulation 2017/746, Art. 2, definition 38). This association is a fundamental factor in the justification process for development and production of IVD devices. 

At Qarad, we offer a service of providing scientific validity reports that follows the procedures as stipulated by the IVD Regulation (Annex XIII, 1.2.1). The service is entirely based on a systematic literature study and involves:

  • Identification and revision of the scientific validity claims in the intended purpose of the IVD device, in collaboration with the customer
  • Systematic search and selection of peer-reviewed literature on each scientific validity claim
  • Critical evaluation of the literature and writing of the scientific validity report
  • Documentation of the systematic literature procedures in three documents:
    • Literature search and selection protocol
    • Literature selection tables
    • Literature search and selection report
  • Revision cycle with the customer to further guarantee that the scientific validity is adequately established

Why Qarad?

Experience with Scientific Validity Report writing

We created Scientific Validity Reports for many reputable companies before.

See our facts overview below.
Regulatory Experts in IVD
 

 

Qarad has many years of experience in the European IVD Regulations which allows us to understand the bigger picture.
 

Proven expertise

Efficiency
 

We can provide you with a complete package performance evaluation documentation:

  • Scientific Validity Report
  • Clinical performance report
  • Analytical performance report
Personal approach

We follow your specific demands and are in constant interaction to fulfill your needs.

Independence

We make sure that the quality and content of the Scientific Validity Reports is consistent and does not depend on the individual visions of each expert within the company.

Reduced burden for your employees

Avoid overwhelming your employees with the excessive work which comes with the pressing demands of the new IVD regulation.

Facts

  • Qarad has already written more than 100 Scientific Validity Reports, for very divers markers.
  • We have 9 different customers who outsourced their Scientific Validity Report writing to us.
  • 4 of those customers belong to the Top 10 IVD companies.

Contact us for more information

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