Medical Devices

At European Regulatory Affairs Limited, we utilise an extensive network of both internal and external dedicated experts to provide regulatory support to ensure your medical device or IVD makes it to market.

Our knowledgeable experts can provide support from the classification to the qualification of a device, from conformity assessment to post-market surveillance and all the technical documentation in between.

So if you need help with your medical device, whether it be a low tech, high tech or custom-made.