Non-destructive testing methods are critical in characterizing the properties and features of any material or product...
Design Controls
Mitigating Bias for Medical Devices
Human Factors Engineering is a major component of the Design Controls process for Medical Devices. Understanding how...
Design Controls for Medical Device Data Systems
Medical Device Data Systems (MDDS) are hardware or software products that are intended to transfer, store, convert...
What is Design of Experiments?
Design of Experiments, or DOE as it is commonly known in the industry, is defined as a “branch of applied statistics...
Design Controls
If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 states...
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