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

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

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

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

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

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

5 Ways a Quality Management System Enhances your Medical Device

The FDA outlines specific requirements for developing a medical device. These requirements necessitate a product development process conducted in progressive stages. This

Infographic explaining how quality managment and ISO 13485:2016 can make or break your medical device

Quality Management Systems and ISO 13485:2016 Infographic

Need help developing an ISO compliant QMS? Speak with one of our experts and get answers to all your project questions. Contact

Medical Device FDA Regulation and Classification Infographic

Need help classifying your medical device? Speak with one of our experts and get answers to all your project questions. Contact Us

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