The Beyond Compliance Advisory Group will use available data to monitor the early performance of new or modified implants that come within the Beyond Compliance service, in order that any potential problems relating to a product or its surgical use can be identified before large numbers have been implanted. The Beyond Compliance Advisory Group recommends a step by step introduction to the market, the speed of which depends on the perceived “risk” that the group attaches to the product.
To act as an independent data monitoring committee
for post-market clinical follow-up data on new products being collected through the Beyond Compliance platform including an analysis and assessment of individual adverse events, looking for early signals of possible problems and advising on consequential actions. This involves regular feedback to both manufacturers and participating clinicians.