Posts Tagged Norm Howe
Where Will FDA Target Next? What IVD Manufacturers Should Know Before Their Next FDA Audit
Medical device manufacturers are always interested in knowing what FDA’s next area of focus will be. Well, if you’re an In Vitro Diagnostic manufacturer you might review your measurement systems. Medical device manufacturers know that their production processes need to be validated. Process validation, as you know, depends on a foundation of measurement. The testing [...]
Read moreHow to Evaluate the Quality of a Dietary Supplement
So, you’ve found a Dietary Supplement that exactly fits your special need. The information on the supplier’s website appears to be consistent with everything that you’ve read and heard, and now you’re ready to buy. But there are questions on your mind. “What is the quality of this product that I’m buying?” you ask. “Can [...]
Read moreOff-Label Use of Medical Devices
How can a medical practitioner decide whether a medical device that they want to use for one of their patients is legal and approved by the Food and Drug Administration? When a patient comes into a physician’s office the patient is looking for the best, most modern care they can get. And a physician certainly [...]
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