In order to market a medical device intended for human therapeutic use, a regulatory body requires evidence that it is both safe and effective. Clinical information is necessary to demonstrate the benefit of using a device against the risks associated with its use. A manufacturer might demonstrate safety of a device by conducting a clinical literature review for similar products but if clinical data are limited, a manufacturer must generate clinical evidence by conducting clinical investigations.
Quality First International’s Clinical Trials Program is designed to fulfil the US Food and Drug Administration, UK, European, Australian, Japanese and Canadian medical device clinical investigation requirements plus recomendations and guidelines such as ICH. Depending on our clients’ clinical needs, QFI can conduct an extensive literature review to identify relevant clinical data or manage an entirely new clinical investigation to verify the performance and safety of a specific medical device. As a Clinical Research Organisation, Quality First International manages, plans, designs and implements every aspect of the clinical trials process on behalf of our clients, working to international standards and regulations. QFI aims to ensure that our clients’ medical devices gain global regulatory acceptance and to provide quality assurance at any stage of the clinical trials process. QFI is experienced in preparing clinical trial applications for example, for:
- The US Food and Drug Administration
- Europe’s directives including the Medical Devices Directive
- The Japanese Ministry of Health and Welfare
- The Canadian Medical Devices Conformity Assessment System
QFI also accommodates WHO and other recommendations for clinical research in human subjects and has produced or helped development of ethics committees in various parts of the world.
Quality First International has extensive experience in the following:
- Submitting applications to the appropriate body
- Performing feasibility studies
- Designing clinical trial protocols
- Preparing Case Report Forms
- Investigator and site selection
- Coordinating clinical trials
- Analysing clinical data
- Outlining key results in a technical summary
- Preparing Interim and Clinical Investigation Summary reports
- Preparing final reports
- Conducting post-market studies
QFI provides independent audit of the clinical trial including investigator site audits trial master file audits and database audits.