Question
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...
Hello, i'm working in spinal implant manufacturing company. DHF formalises input, output, verification, validation, review and transfer. After post production we continue to create revised DHF for design changes. Our DHF is system based e.g. Cervical...
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...
I want to ensure we maintain conformance to 820.80 and also incorporate the risk-based approach to acceptance activities. We are looking for potential opportunities to reduce or eliminate inspections based on the item such as supplies vs raw material...
Under the European Regulation there are many cosmetic products with very low amounts of acidic components (such as glycolic acid, trichloroacetic acid, salicylic acid, lactic acid, etc).Active ingredients in higher concentrations (such as in the case...
Most regulatory experts work on medical device OR in vitro diagnostics--not both. Making the switch from one type of 510(k) to another is not that hard.First, the submission content and format requirements are the same. There are still 20 sections, a...
Hi everybody! Can someone tell the difference between the sentences: 1- " shall document a procedure" and 2- "shall document procedures"? Does 1 mean that we need to implement one procedure per subject ( internal audit, control of documents..) and 2 ...
Guest author Mark Proulx has seen a lot of head-shaking choices from prospective clients. I say "prospective" because, after conversations like the one below, he stayed clear of their impending disaster. Do yourself a favor: Don't say this to your au...
Dear All.... Could anyone please let me know the procedure for "how to select and contact a Notified Body?"
Even before the FDA’s final rule was published for UDI in 2013, companies were implementing UDI systems. What has not been clear is how the FDA would enforce UDI compliance. The most logical methods of enforcing UDI compliance are:1. require a draft ...