In November 2018, FDA released its Medical Device Enforcement and Quality Report. In the report, the agency reveals how its initiatives on inspecting medical device manufacturers have grown in recent years. In the last decade alone, device inspections have increased by 46 percent.
These results have two major implications for medical device manufacturers. First, it means that the frequency of FDA inspections is on the rise and will likely continue in that trend. FDA and other regulatory bodies appear to be looking toward expanding industry oversight as we move into a new era of medical device manufacturing—one that takes advantage of the rapid pace of technology to provide more dynamic and integrated care for patients around the globe.
Second, more FDA inspections occurring mean that medical device manufacturers need to be prepared for inspection. Approaching regulatory audits with a “be prepared” attitude is necessary to ensure your organization gets set ahead of time. But what are some ways to be ready for regulatory agencies when it comes to audits and inspections?