October is the month that is designated internationally to bring awareness to the impact of breast cancer. The best screening tool to find cancer remains the mammogram. A mammogram is a low-dose x-ray picture of the breast. As in any cancer, early detection is key.
There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.
In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.
One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.