CE Hosting – Provision of certifications
At the customer’s request, we are also able to carry out a “product certification” in our name. WQS is certified by the notified body TÜV Nord Polska according to ISO 13485 and the annex of the directive on Medical Devices. This approach can be useful for sales-oriented companies that do not have a permanent location or lack the human resources to familiarize themselves with the regulatory requirements for Medical Devices.
This approach also offers an advantage with regard to unannounced audits. At the same time, the existing infrastructure can, of course, also be used to successfully manage meetings, workshops or customer audits.
A current example is a certification for an invasive class IIa product (vaginal pessary) for a distribution company near Berlin. The issued certificates can be viewed here.
