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6 Things to Know About Human Factors Engineering of Medical Devices
Human factors engineering is a complex and multi-disciplinary area of risk management. It involves knowledge integration from various scientific fields, including psychology and engineering. The FDA plays a key role in regulating human factors engineering in medical devices in order to reduce the risk of injury to the user and the patient. The goal is to identify any errors that can result in serious harm before they happen and reduce or eliminate them. What is human factors engineering? The FDA defines human factors engineering as:"The application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users ... Read More
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6 Things to Know About Human Factors Engineering of Medical Devices
Human factors engineering is a complex and multi-disciplinary area of risk management. It involves knowledge integration from various scientific fields, including psychology and engineering. The FDA plays a key role ... Read More

Verification vs. Validation of Medical Devices
Design verification and design validation are important quality assurance activities during medical device design that help ensure a medical device is high quality and fits its intended purpose. The results ... Read More

Case Study: How to Reduce Prototype Cost with 3D Printing
The challenge The medical device market is historically fueled by innovation. The robotic surgical space is an area with a lot of device development and has many players competing at ... Read More

How to Design for 3D Printing
3D printing is a prototyping method that "prints" a three-dimensional physical object in layers from a digital file. Compared to traditional prototyping methods, 3D printing is fast and low-cost. While ... Read More

How to Perform a DFMEA In 9 Steps
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

How the FDA Defines and Evaluates Medical Device Biocompatibility
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

All About FDA 21 CFR Part 820 and cGMPs
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