If you work for a medical device manufacturer and are tasked with managing customer complaints, you just might want to scream. However, if the product complaints are beginning to pile up, take notice, for your customers are trying to tell you something.
Holding a management review meeting is one of the most basic elements of an effective quality management system. If your organization is not actively pursuing management review meetings, start by holding one as soon as possible. Remember: The buck stops with the management team!
The Form 482 is the vehicle employed by FDA to announce their presence for an establishment inspection in the United States.
FDA considers the Design History File documented evidence that a medical device was designed and developed in accordance with §820.30; if documented evidence does not exist, FDA will issue a Form 483 observation or even a warning letter.
This week, we dive into a topic that is not frequently addressed by writers: the selection and training of quality management system auditors.
In a perfect world, there are no taxes, Cuban cigars are legal, good bourbon is always free, and the San Jose Sharks finally win Lord Stanley’s Cup. Unfortunately, this world is far from perfect and the medical device industry even more so.
There’s just one takeaway for this week: be meticulous and thorough in the preparation of the PMA. FDA considers PMA devices high risk, and as such, expect an entirely new level of detail versus the 510(k) process.
FDA premises device classification based on risk: Low-risk devices are Class I and high-risk devices are Class III. Then, just maybe, Class II is medium-risk? Well, sort of.
Although the regulatory burden is greatly reduced for Class I devices, manufacturers of Class I devices are still required to register their establishment with FDA, list their device(s) in the FURLS, and maintain general controls.
In FDA speak, the phrase “failure to define” is code for “your organization has screwed up and missed something!”
