Question
Some organizations view regulatory and technical standards compliance as a goal to be achieved. Others simply a real pain-in-the-butt to accomplish. While I will be the first to agree that some of the seemingly excessive documentation requirements in...
CAPA-Corrective and preventive Action...Every day a seminar on CAPA is being held somewhere, it’s one of the simplest, but most misunderstood process we deal with every day!Many companies have not only their "formal" CAPA process, but also have sever...
If you quickly scan through the Federal Register looking for notices that affect either the drug or device industry, you may have missed seeing something important on September 25th. The title of the notice for a proposed rule was “Clarification of W...
Tom Nonnemaker
Experienced Project/Program Manager, NPD, Acquisitions, Supply Chain Management, Class I & Class II Medical Devices
October 2015
I'd be curious if anyone is 'in the know' on awareness of any general strategy for compliance to the UDI ruling for non-sterile implantables (such as spinal implants) ? The FDA gave us an extension to Sep 2016 to implement, but there is no real clear...
Since the EN version of ISO 14971 was released in 2012 I have received lots of requests from clients to help address nonconformities from Notified Body auditors. In the past year the frequency of this nonconformity has increased substantially.The FDA...
Given the increasing frequency of infections issues related to reprocessing of duodenoscopes at FDA and the subsequent remedial post market studies they are requiring, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465639.htm?source=gov...
source: https://www.linkedin.com/groups/2070960/2070960-6060571923853701124
Dear all, Does EU call out a specific amount of years an electromechanical medical device is required to last in its lifetime?Any comments or links to information would be greatly appreciated.Kind regards,Tomsource: https://www.linkedin.com/groups/20...
If you have a moderate risk device you probably will submit a 510(k) before applying for CE Marking, because some of the requirements for a technical file are more challenging than European requirements.Risk Management FileThe FDA only requires docum...
Hi All,Have you noticed some confusion out there in the use of the terms verification and validation as it relates to medical device software? It seems that some say that validation is the actual testing and verification is all of the other activitie...
