Medical devices encompass a wide range of products. Today, there are
more than 500,000 medical devices on the European market. Some are
closely regulated and need extensive clinical documentation, whereas
others have a classification that makes the path to CE marking and
market access shorter.
For medical device clients we have established a dedicated team with experience and competence with the regulatory requirement from the different phases in the product development; from evaluation of the CE classification, creating documentation and clinical evaluation report to interaction with Notified Body. We have experience in planning, conducting and reporting of studies for medical devices as well as expertise to undertake health economic evaluations.
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