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.