Medical Device Design Controls Explained
Design controls are a set of practices and procedures incorporated into the design process as part of current good manufacturing practice (cGMP)
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Verification vs. Validation of Medical Devices
Verification and validation are design controls required by the FDA to ensure the medical devices you manufacture are safe, effective, and fit
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
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. Request