Scientific validity reports

Based on in depth literature review

Scientific Validity Reports

As per IVD-Regulation 2017/746, the performance evaluation of an IVD Medical Device consists of three pillars:

  • Scientific Validity Reports
  • Analytical Performance Studies
  • Clinical Performance Studies

Qarad can provide you with the complete Performance Evaluation
documentation package or one or multiple parts.

Click here for more information about the Analytical and Clinical performance Studies.

Analytical and
Clinical Performance Studies

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 can provide you with scientific validity reports that follow 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 for 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 have created Scientific Validity Reports for many reputable companies before.

See our fact overview below.

Regulatory Experts in IVD

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

Proven expertise

Efficiency

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

  • 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 diverse markets.
  • We have 9 customers who have outsourced their Scientific Validity Report writing to us.
  • Four of those customers belong to the Top 10 IVD companies.

Contact us for more information

Qarad IVDR Conference 2022

NHOW Brussels

October 11-13

Get the latest IVDR insights during our three-day conference, including a pre-conference workshop.