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 […]
Category: Blog
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 […]
Meet Tyler! Our New Senior Design Engineer
Tyler Luneski is the latest addition to Synectic’s team of talented design and development engineers. Join us, as we sit down with […]
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 […]
Say Hello to Hope Our Latest Team Member
Synectic is excited to announce the addition of Hope Kavulich to our growing engineering team. Hope, a recent graduate of Quinnipiac University’s […]
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 […]
Mack Molding Expanding Vermont Facilities
Faced with overwhelming company growth, Synectic’s parent company, Mack Molding, recently expanded its northern division by leasing 25,000 square feet in Shaftsbury, […]
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 […]