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.
Our core competencies in medical devices:
- Management of complex study designs
- The challenge to handle in parallel the regulatory needs for studies combining medical device and drug
- Regulatory advice on clinical study design and submission procedures
- Knowledge of pre- and post marketing authorization study requirements
Therapeutic approaches include:
- Angioplasty devices (stents and balloons; drug eluting or resorbable devices)
- Ablation devices
- Biodegradable and non-biodegradable polymer devices
- Subdermal fillers (incl. application devices)
- Implantable medical devices based on flexible and textile materials
- Drug delivery devices
- Active medical devices (e.g. treatment of neurological disorders)
- In vitro diagnostic devices (IVDDs)
- Hemodialysis and hemofiltration devices
- Vascular grafts
- Eye drops
- Externalized pulmonary venting systems
- Ultrasound devices
We have performed international first-in-man and first-in-patient studies.
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