Clinical Investigations
It may be necessary to carry out a clinical investigation to demonstrate the medical device complies with the relevant Medical … read more »
Conformity Assessment
Once the class of product has been determined the product can be assessed by a formal conformity assessment procedure, which varies … read more »
Medical Device Classification
Medical devices fall into 1 of 3 categories, as each type is governed by a different EU Regulation or Directive: … read more »
CE Marking
The CE mark What is a CE mark? Medical devices which are to be placed on the market in the … read more »