When to perform a literature review?
A literature review is a mandatory part of each clinical evaluation. Public literature and safety databases will be systematically searched, according to predetermined keywords, for both clinical state of the art and experience with similar devices. Found literature will be subjected to a critical appraisal and analysis, according to applicable regulatory standards. Results will be input to the clinical evaluation or risk management process.
Can a literature review replace a clinical investigation?
When your device is equivalent to an approved medical device in the market, a literature review can provide clinical data to support the safety and performance of your medical device. Depending on the quality and extent of the found data, a part or even all the medical claims of your device might be covered. Any remaining gaps in clinical evidence will have to be covered through additional clinical investigations.
Qserve has a dedicated staff with extensive experience with medical devices and clinical practice, which is essential when choosing proper databases, selecting keywords, and performing a systematic review.