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How to Perform a DFMEA — Design Failure Mode and Effects Analysis
FMEA stands for Failure Mode and Effects Analysis and is a risk management tool for identifying potential failures. FMEA assesses the severity of the failure risk and how to diminish ... Read More
What Is Biocompatibility? ISO 10993 Testing for Medical Devices
Biocompatibility testing is the best way to evaluate medical device safety. Through biocompatibility testing, the FDA confirms that either there are none or few local or systemic effects. Local effects ... Read More
A Breakdown of the FDA’s Medical Device Record Requirements
Listed within the FDA’s 21 CFR 820 are detailed regulations governing medical device records and quality systems. These regulations identify five record types that medical device manufacturers need to maintain ... Read More
FDA 21 CFR Part 820 — Quality System Regulation for Medical Devices
21 CFR Part 820 is a set of FDA regulations that govern medical device quality systems. Detailed within are current good manufacturing practice (cGMP) requirements ensuring medical devices distributed within the ... Read More
FDA Medical Device Regulatory Controls Explained
Part of the Medical Device Regulation Act involved establishing specific regulatory controls for each of the three classes of medical devices. The higher the class of device, the more risk ... Read More
How the FDA Classifies Medical Devices
In 1971 a new IUD called the Dalken Shield entered the market and was implanted in almost 3 million women in the United States. Over the next few years, the ... Read More
Pilot Production — Bridge Manufacturing and Production Readiness
Pilot Production is the beginning of the end of product development. Pilot Production is part of our contract manufacturing services and is used at the end of engineering development during ... Read More
9 Prototype Testing Methods to Prove Your Invention Works
Prototype testing provides a cost-effective method for ensuring products meet user requirements and regulations. Simple proof of concept tests can predict future design problems and determine if further development is ... Read More
