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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. These include the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Quality System Record (QSR), and Complaint Files. Manufacturers must keep these records for the anticipated lifetime of the medical device or a minimum of two years from the date of first distribution. Additionally, they must store these records in a way that is easily accessible to anyone within the organization involved in quality-related activities. While ... Read More

ALL WHITE PAPERS

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
FDA regulatory controls

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

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
dfm design for manufacturing

3 Things to Know About Design for Manufacturing (DFM)

DFM stands for design for manufacturing and is a part of the product development process initiated when your design shifts from prototype development to new product introduction. When done correctly, it can lower ... Read More
how to make a prototype

How to Make a Prototype in 4 Easy Steps

Once you have identified your product specification and brainstormed concepts for how your idea aligns with those product specifications, it is time to make a prototype. Prototypes are a great way to showcase your ... Read More
pilot production

4 Tips to Improve Your Pilot Production Build

The Pilot Production Phase is the beginning of the end of product development. Pilot Production is just a step away from contract manufacturing and is used at the end of ... Read More
prototype testing methods

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