Question
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...
I have two clients who source parts from – you guessed it – Wuhan, China. One's basically out of business, so he postponed a medical device marketing project with me. Then there's the 10x Medical Device Conference in April. My beloved alumni say, "Un...
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...
You receive parts from a supplier. If those parts are made into subassembly at your location, you classify them as such. When the part is made at the supplier, it could one part or a subassembly. How do you classify as such into your system?source: h...
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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...
Over the years, a number of trucking, shipping, and delivery companies have asked me how they can get a foot in the door of medical device companies. And this week a group member asked, "What do the top medical device companies do to warehouse their ...