We help medical device companies develop their clinical strategy and provide solutions for clinical evidence collection activities.
Quality procedure set-up support and compliance review for EU clinical activities.
PMCF studies are designed to identify the potential for residual risks of a CE Marked device, and to collect data and gain clarity regarding the long-term clinical performance of the product.
Almost all clinical investigations with medical devices require one or more reviews of documents, systems, and procedures.
Are you preparing to undertake a clinical trial in Europe? Do you need help with investigator or site selection?
The clinical trial protocol describes the objective, rationale, design, methodology and organization of a clinical study.
Manufacturers of medical and in vitro diagnostic (IVD) devices based outside the European Union are required by law to designate an Authorized Representative in order to carry out clinical studies within Europe.