Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation, or provide evidence as to why a clinical investigation is not necessary. Sample activities in the clinical space that we perform for our clients:

• Generation of the Investigator’s Brochure; Case Report Forms, Informed Consent Documentation Packages, Instructions for Use.
• Assistance in the generation of the Clinical Investigation Plan, monitoring plans, clinical adjudication processes and opening of clinical sites.
• Competent Authority and Ethics submissions and approvals for clinical investigation commencement.
• US IDE and IRB approvals, communication with the FDA’s CDRH branch to review and obtain agreement on clinical plans.
• Early Feasibility Study Program (EFS) approvals with the FDA.
• Safety and vigilance/medical device reporting for clinical devices.
• Generation of Clinical Literature Reports, Clinical Investigation Reports and Clinical Evaluation Reports for regulatory submission.