Here are the four critical questions to ask before taking on the literature search and review process.
Whether your organization is about to bring a new medical device to market or preparing to submit a periodic safety update report, you must demonstrate that the device complies with all the relevant regulatory requirements. Additionally, more than establishing that the device delivers its intended benefits, you must also identify all known risks, capture any adverse events, and report the findings along with all the appropriate evidence.
It’s a big and difficult job, and one that relies upon efficient and effective processes—as well as experts to run those processes. And where auditors are concerned, process is the name of the game. Consequently,...