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.
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›