eX-Path provides a unique service to companies that produce and / or sell IVD reagents. eX-Path has the professional knowledge and facilities available to validate the specificity, sensitivity and stability of your IVD products. In addition eX-Path provides you with a risk and design management assessment and the mandatory ISO documentation.
eX-Path provides you with high quality, high resolution whole slide images that can be exclusively accessed by those that you trust. Upon request eX-Path will provide you with eXclusive user name(s) and password(s).
Validation of IVD products.
Validation means that every product must be tested. This can be antibodies, detection systems, substrates etc etc.
Documentation according to ISO regulations
Any validation starts with the description and documentation of the specifications for user requirements, reagent function and performance.
eX-Path manages the validation program and the activities to achieve and maintain compliance with IVD regulations.
eX-Path provides you with accepted document formats.
Simply send us your request using the contact form and we will come back to you for details.