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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



Everything You Need to Know About Nitinol

Nitinol (pronounced night-in-all) is a metal alloy with unique properties and uses. This amazing metal alloy can “remember” or change shape depending on temperature. Before you decide whether to use ... Read More
product design experience

3 Reasons Experience Matters in Product Design

In today’s competitive design and manufacturing environment only the strongest and most prepared survive. Both Synectic Product Development and Mack Molding have long track records of success, proving that both ... Read More
Medical Device FDA Regulation and Classification Infographic

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 About Synectic Product Development: Synectic Product Development is ... Read More
how to develop concepts

How to Develop Concepts in 6 Easy Steps

Like all phases of product design, concept development follows a proven process for success. This process includes creating a design history file, reviewing the product specification, and brainstorming concepts. Extra ... Read More
project setup

Set Up Your Product Development Project in 5 Easy Steps

Once you have selected a product development company, you may be asking yourself what the next step in the product development process is. While each company approaches product design differently, ... Read More