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.
You can find all information and details related to the prequalification program on the WHO website: here.
The WHO prequalification of diagnostics program is decomposed in 3 phases:
- Dossier Review
- Site Inspection
- 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.