In-Vitro Diagnostic IVD 98/79 directives

With the planned revison of the IVD directive, the manufacturers need to re-evaluate their regulatory strategy.

Our services covers the following areas: 

  • Confirmation of the device class as per GHTF classification
  • Setup and ISO 13485 certification of a simple and compact Quality Management System
  • Update of the regulatory technical file

For more information on IVD conformity, please send us a message through our contact form and we will contact you within no time.