The medical device sector presents with an extremely broad spectrum of continuous innovation, including hundreds of different technologies and a whole universe of types of products in the fields of prevention, diagnosis, therapy, after-care, rehabilitation and nursing care. At the same time, regulatory requirements for placing medical devices on the market, and thereby the need for clinical data, will become substantially more demanding.
Our experienced team of specialists has completed a high number of clinical studies spanning a wide variety of medical devices with or without CE mark.
We have performed international first-in-man and first-in-patient studies.
Senior Manager of Clinical Affairs
“Partnering with FGK on multiple full-service projects has been an great experience. Their deep long-standing expertise in the medical technology field, direct and open communication, and truly collaborative approach have made them a valuable extension of our own team. We highly value their professionalism and dedication, which have contributed significantly to the success of our clinical programs.”
If you are looking for an expert team guiding your innovative medical device through the increasingly demanding clinical study framework, get in touch with us