European Authorized Representative for Regulatory Affairs
QNET offers Authorized Representative services for all risk class devices in Europe including:
QNET BV
as the name you may print on your CE-marked devices and related printed materials i.e. labels, instructions for use, inserts, manuals, websites.
Registering of your CE-marked devices with the appropriate Competent Authorities and holding your technical file available as required.
Monitoring changes to directives and regulations and contact you only when there are issues that deserve your attention.
Interfacing on your behalf between Competent Authorities, Notified Body and your distributors or end-users.
Performing an annual review of your technical file content with a reminder to update or change existing documentation.
Protecting your documentation's confidentiality by contractually agreeing to show them to the Competent Authorities only.
Notification of the Competent Authorities of serious incidents.
Co-signing your Declaration of Conformity.
On-site visits.