Clinical Evaluation Report Compilation and Consulting

The compilation of clinical data that proves the safety and efficacy of a medical device is important for all medical devices. But increasingly (especially in Europe), regulatory authorities are requiring clinical evaluations to be included in technical documentation. This especially applies to Class I devices sold for which clinical data may simply be comprised of published articles. The compilation of a clinical evaluation report may seem unnecessary for devices that have been on the market for a long time, but regulatory authorities are definitely looking at this more closely.

Let Emergo help you prepare a Clinical Evaluation Report for your device(s)

Clinical evaluation reports should be compiled and written as a separate document and Emergo Group can help analyze existing data that may include:

Clinical investigations performed using your device
Published clinical investigations or other studies performed using your device or similar devices
Clinical experience of your device or similar devices
Unpublished or historical data

We can also write the clinical evaluation report for you after reviewing the data above as well as the risk assessment and labeling. If shortfalls exist in the availability of clinical data needed to satisfy regulatory requirements, we will make recommendations on how to acquire supplemental clinical data. Emergo specializes in international medical device regulatory affairs, so we understand the specific requirements of the revised European Medical Device Directives plus US FDA, Canadian, Australian and other international requirements.