Scenario: You spent months and hundreds of thousands of dollars customizing a test method in verifying and validating the design of your new device. You included the data with your premarket submission to FDA, and their response was a list of questions as to why you think the test method is adequate and valid. How should you handle this situation?
Purchasing Controls is the only section of the QS Regulation and ISO Standard in which business and quality systems management overlap ever so blatantly. And, you can expect strong attention to this area during an FDA inspection.
In this complimentary 20-page report, ORTHOWORLD zeroes in on the Japanese Orthopaedic Market. Large joint reconstruction is the dominant segment, with entities like Aesculap, DePuy Synthes, Medtronic, NuVasive, Smith & Nephew, Stryker, Tornier and Zimmer Biomet all holding a local presence.