A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.
A high degree of risk identification and management throughout the supply chain is what establishes a company as ‘world class,’ says Steve C de Baca – Senior VP, Global Quality & Regulatory, Beckman Coulter Diagnostics.
Rx-360, an international pharmaceutical supply chain consortium, which helps its members share best practices to ensure the integrity of the healthcare supply chain, is now gearing for growth in the device space. What lessons can device makers learn?
Whether you are thinking about Annual Planning or Year End Closing, we are in a time of reflection and resolve to improve. Over the years I have learned to choose a limited number of improvement efforts, apply management resources, then measure with them regularly for progress and impact. The costs of not focusing sufficiently in a few key areas can ruin a great idea.
We now test the possible causes against the facts in the IS / IS NOT Diagram to see which ones make sense. This is where the investments made in defining the problem and getting the facts pay off!
UDI is finally upon us, so embrace the change and begin working toward compliance.
Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit a device manufacture, resulting in Dr. D’s favorite six-letter word – RECALL.
The third step of the investigation is to develop a list of possible causes. All too often investigators stumble at this point as they rely solely on the fish-bone diagram.
If a medical device establishment is manufacturing sterile medical devices, make sure that environmental monitoring and the calibration and servicing of environmental control systems are part of the product realization equation.