I had the occasion to work with Irene to write the Literature Review, State of the Art and our Clinical Evaluation Reports according to the MEDDEV 2.7.1 rev. 4. We manufacture class-III Medical Devices and three lines of products had to be completely updated within a limited time. The task was huge and having Irene working as a medical writer was a real asset for the team. She knows very well the MEDDEV, and she took time at the beginning to understand the products’ applications; this have made an enormous difference.
Previously, we had always worked with a CRO and I was not really satisfied with the result because I had the feeling that they were doing the same standardized work for every product, every company. Irene listened to our specific demands and followed our requirements. She has been very flexible and able to adapt at any step of the project. She communicated a lot with the team and asked a lot of accurate and relevant questions that made the quality level (content and form) of the final reports really good, and better than what has been done by the CRO before.
I highly recommend the services of Irene as a medical writer.