WHO prequalification of diagnostics

WHO prequalification of diagnostics If you are looking to expand your market and apply for the WHO prequalification

WHO prequalification of diagnostics

If you are looking to expand your market and apply for the WHO prequalification of diagnostics program, you may wonder what are your option and how to proceed.

We are here to help you find solutions. WHO (World Health Organization) has one of the most strict requirements in the world for medical devices, you will need help !

We’ve helped several companies to get through and you’ll just have to step in their footprints.

Regulatory process

You can find all information and details related to the prequalification program on the WHO website: here.

The prequalification program is decomposed in 3 phases:

  1. Dossier Review
  2. Site Inspection
  3. Lab evaluation

We can provide assistance at different stages. It could be at the beginning when you want get all prepared or you could be in the middle of a submission, looking for help to improve your response to the requests from WHO.

Execution strategy

Our execution strategy incorporates proven methodologies, extremely qualified personnel, and a highly responsive approach to managing deliverables. Following is a description of our project methods, including how the project will be developed, a proposed time line of events.

How Kobridge helps for the WHO prequalification:

  • Technical document preparation before review by WHO
  • WHO mock inspection service
  • Training
  • Review of the technical documentation
  • Preparation of the inspection
  • Remediation following non-conformities from WHO

WHO

Technical/Project Approach

Here is how we will work together:

  1. Preliminary analysis
  2. You receive an “assignment letter” to allow us to review your product documentation.
  3. You receive a Non-Disclosure agreement
  4. Based on the information collected during the preliminary analysis, we send you the detailed estimate of the complete registration process
  5. You receive the “Service Agreement”
  6. We collect documentation for : Dossier Review
  7. We perform a pre-assessment of your readiness for WHO inspection
  8. We review all documents for Dossier review
  9. We submit the pre-submission form
  10. We assist you during the Dossier Review
  11. We assist you during the WHO inspection

 

checklist

Resources

We use the project management platform “Basecamp” to manage our projects. That way you also have access to the same platform, you can see the progress “live”, interact with our team and have full transparency.

We consider we fail if you ask about the progress of the project so we keep you informed on a bi-weekly basis at least.

We will appoint a project manager and its assistant who will be in charge of the whole process.


 

If you wish to apply for the WHO prequalification program you can contact us for a preliminary discussion.