Your contact for procedures according to Annex XI(B) of the MDR
Have you developed a novel medical device? Perhaps you are a team of tinkerers still in the early stages of setting up a company? Then you need a valid estimate of the market resonance for your product in order to find investors.
Or maybe you want to use your device in research and produce only a very small number of units for the time being. In both cases, product certification is the appropriate path to CE marking, on which we will be happy to accompany you.
This conformity assessment procedure does not require a certified quality management system, but each product must be tested and approved within the framework of an individual inspection or on a statistical basis.
Berlin Cert, originating from the field of product testing, has accumulated extensive knowledge over the past decades. In combination with our testing laboratory, we thus have the perfect conditions to test your product with us and to perform a product certification according to Annex XI(B) of the EU Regulation 2017/745 ("MDR").
Our competent team is available for you at any time.
We are looking forward to meeting you!