Listed within the FDA’s 21 CFR 820 are detailed regulations governing medical device quality systems and records. These regulations identify five record types that medical device manufacturers need to maintain. These include the Design History […]
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 United States are effective, safe, […]
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 associated with it, and the […]
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 CDC noted a disproportionate number […]
DFM stands for design for manufacturing and is a part of the product development process initiated when your design shifts from prototyping to new product introduction. When done correctly, it can lower your manufacturing and production time and […]
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 ideas. Uses for prototypes include […]
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 engineering development during new product introduction to […]
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 worth the effort. By starting […]
Brainstorming can be a fun exercise to solve a particular problem or expand on an idea. As an inventor, you probably already have an idea of where you would like to start. If not, we […]
No matter what your product is, the end goal is to make it to production. Make sure your product is ready by watching this free webinar. Synectic President Adam Lehman will explore common mistakes companies […]
