Device Classification

Choosing the right device classification from the beginning is crucial to avoid going down the wrong path. However, this is not always an easy task for MedTech and Pharma companies.

At Technolution, our regulatory affairs team are ready to help, when clients hit the wall during the device classification process. For some clients, internally disagreeing about the classification is the culprit. Others need a set of expert eyes to determine, whether a device classification is correct. Yet another client may need help resolving disputes with a notified body over a device classification.

Being too conservative by placing a device in a higher class than necessary may result in time-consuming and expensive work maintaining the certification. On the contrary, failing to submit a device, and consequently losing the license to sell, may be the result of too low a device classification.

Our regulatory affairs experts help MedTech and Pharm companies avoid making the wrong device classification and save organizations from the serious consequences that follow.