Europe | Clinical Research

MDR, IVDR and ISO 14155 clinical activity compliance support

Quality procedure set-up support and compliance review for EU clinical activities.

Europe | Clinical Research

European Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices

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.

Europe | Clinical Research

Medical Device Clinical Research Study Audits and Quality Control

Almost all clinical investigations with medical devices require one or more reviews of documents, systems, and procedures.

Europe | Clinical Research

Medical Device Clinical Trial Management and Monitoring

Are you preparing to undertake a clinical trial in Europe? Do you need help with investigator or site selection?

Europe | Clinical Research

Medical Device Clinical Trial Study Design and Protocol Development

The clinical trial protocol describes the objective, rationale, design, methodology and organization of a clinical study.

Europe | Clinical Research

European Authorized Representative for Clinical Trials

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.