In my position, a variety of questions are posed to me from the industry. Fortunately, I find it fun to research these topics and find answers for those who need help.
In keeping with, I'd like to share with you the quality assurance-type questions that I am asked most frequently and direct you to where you can find clear answers.
What is AIAT?
This stands for assemble, install, adjust and test. It is an acronym used by the FDA in 21 CFR 1020 concerning assembly services for diagnostic imaging equipment. Read the article below to learn how AIAT affects you and your medical devices.
My 2579 form has disappeared and the auditor is looking for it. Where do I get another copy?
In the midst of an FDA or state audit, this could prove to be a serious problem for your site.
Does my c-arm need lead shielding?
In short: maybe. Check this article for more details and how to find out for sure.
What does it mean to be an ISO 9001 registered company?
For buyers, this certification can be a telling feature when seeking an equipment refurbisher.
If you have other quality assurance questions and aren’t sure where to find your answers, send me a message. I can help you find what you need. And, who knows? Your question might end up the topic of my next blog article.