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human factors engineering of medical devices

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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human factors engineering of medical devices

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

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

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

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

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
FDA biocompatibility evaluation

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
medical device record

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
21 CFR Part 820 and cGMPs

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