A surprise visit from FDA and a non-compliant QMS will likely result in devices being identified as adulterated. Entering adulterated devices into commerce in the United States may result in a warning letter.
Process Validation should be considered one of the basic tenants associated with the manufacturing of finished medical devices that are safe and effective in their intended use. However, what happens when a device establishment fails to implement an effective program for process validation?
CAPA Corner: The Case of the Defunct TV
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.
Worldwide Medical Device Regulatory Updates
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.
Purchasing Controls and Supplier Management
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.
Medical Device Supplier Certification: the Rx-360 Approach
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.
