Reporting In

A few weeks ago, I received this message from one of the top Merge execs (emphasis mine):Notification of Enhanced FDA Reporting MethodologyDear Valued Customer,As part of our commitment to ensure compliance and driven by our objective to deliver high-quality medical devices, we want to inform you of a change in our quality management processes to provide greater transparency to our customers and raise the bar on delivering quality in the medical device industry. I also want to take this opportunity to reiterate Merge Healthcare's commitment to implementing corrective actions to ensure compliance with the Federal Food, Drug, and Cosmetic Act and all regulatory requirements. Merge's executive management team takes the FDA’s observations seriously, and we have been fully cooperating with the FDA to resolve any questions or concerns expressed by the FDA.Merge Healthcare has enhanced its FDA reporting methodology to report to the FDA product corrections and removals including those that may be classified by the FDA as Class III recalls. For clarity, Class III recalls signify the lowest potential risk situations, representing minimal impact to patient care. In this context 'recall' can be a form of communication and should not be interpreted as always requiring an update to a product. This change in policy will also increase transparency and notification to the FDA of Corrections and Removals associated with our medical devices. As a result, it is very possible that you will see ...

Source: Dalai's PACS Blog - January 25, 2016 Category: Radiology Source Type: blogs