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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


insert molding

All About Insert Molding

Insert molding is another plastic injection molding process that combines different materials into one object. Unlike overmolding, which involves a two-step process to create a similar outcome, insert molding is only ... Read More

A Guide to Tooling and Mold Design for Manufacturing

Tooling is the backbone of plastic injection molding. Without a proper tool design, your plastic part would never scale up properly. A quality tool design can save you enormous amounts of ... Read More
sheet metal fabrication

An Introduction to Sheet Metal Fabrication

Sheet metal is a versatile medium used in product manufacturing for centuries. With an almost unlimited list of usable metals and an almost equal list of fabrication techniques, sheet metal ... Read More
plastic injection molding machine

9 Things to Know About Plastic Injection Molding

Everywhere you look, most plastic objects in the world around you are created using injection molding. Plastic injection molding has been a reliable, well-established manufacturing process for over 100 years ... Read More
finishing and painting

Finishing And Painting Explained

Finishing involves altering the surface of a manufactured part to achieve the desired appearance or make it easier to bond with or provide durability. The finishing processes used on the ... Read More
quality control

5 Ways a Quality Management System Enhances your Medical Device

The FDA outlines specific requirements for developing a medical device. These requirements necessitate a product development process conducted in progressive stages. This rigor ensures that risk and device effectiveness are ... Read More
plastic resin selection

6 Key Considerations When Selecting Plastic Resin

As a leading contract manufacturer, resin selection is one area of plastic injection molding where we often find the most distinctiveness. When selecting plastic resins you must remember that each ... Read More
inventor cost

The Hidden Cost of Inventing: Fixed-Fee vs. Time-and-Materials

In the world of product development, inventors looking to keep costs controlled are leaning more and more towards outsourcing engineering services to a product development company. As with any client/vendor ... Read More