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We help medical device companies develop their clinical strategy and provide solutions for clinical evidence collection activities.
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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.