The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.
Please ensure that the cleanroom/controlled environment has been properly validated and that adequate ongoing monitoring of the operating environment be sustained.
When it comes to identifying and controlling nonconforming product, place significant emphasis on the need for a robust system, premised on well-written procedures. It is always a bad thing for nonconforming product to find its way into the supply chain.
There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.