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 […]
Category: Blog
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, […]
FDA 21 CFR Part 820 — Quality System Regulation for Medical Devices
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 […]
Hologic Acquires Bolder Surgical
Hologic, Inc., a women’s health leader, recently acquired Bolder surgical for $160 million. Bolder surgical is a privately held medical device company producing […]
Jesse Dlugos Awarded First Design Patents
Synectic is excited to announce that one of our Senior Engineers, Jesse Dlugos, was recently awarded two patents, the first in his […]
Pilot Production — Bridge Manufacturing and Production Readiness
Pilot Production is the beginning of the end of product development. Pilot Production is part of our contract manufacturing services and is […]
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 […]