We review the data presented, provide guidance for the need for any further development, and help in the compilation of the data generated by your organization.
For each product presented to us, we evaluate the appropriateness of the safety and effectiveness data generated. We evaluate the appropriateness of the device description. The alternative practices and procedures available for assessment of unmet medical needs. We search different databases and platforms to check the marketing history of similar products.
Appropriateness of the claimed indications for use, contraindications, suggested warnings, and precautions with respect to the medical device. We evaluate the potential adverse effects of the device on health and possible risks associated with any procedures. Review the non-clinical studies generated by the company or presented by the company as supportive references to determine the adequacy to support health agency scrutiny.
For medical devices the construction material may be critical, we review the appropriateness of the laboratory studies, which may include appropriate mechanical testing parameters on the raw materials or final product. Our review may include animal testing, biocompatibility, sterilization, shelf-life and packaging validation, radiation/imaging compatibility, and data produced by the company. If there are gaps, we shall provide the optimum guidance that is cost-effective, requires the least time/resources, and satisfies the health agency requirements.
