White Papers

Process validation is a critical component of manufacturing that ensures a process consistently produces products that meet predefined quality standards. The validation process typically involves three key stages: Installation Qualification ... Read More

Design controls are a set of practices and procedures incorporated into the design process as part of current good manufacturing practice (cGMP) and in conjunction with a quality system as ... Read More

Injection molding is one of the most popular and cost-effective manufacturing methods to create large volumes of parts. Injection molding can create high-quality parts in a variety of materials. However, ... Read More

In product development, versatility is the key to innovation and efficiency. When creating complex prototypes and low to medium-volume production parts, urethane casting is one method that stands out. This ... Read More

Regardless of what type of medical device you develop, the FDA requires you to follow a regulated process. Each step of the medical device design process lays the foundation for ... Read More

Table of Contents After settling on a winning concept, prototype development is the next step in product development. In this phase, you will transform your drawings and CAD models into physical ... Read More

Concept development is the part of the product development process where you will generate, evaluate, and refine your abstract ideas, turning them into a well-defined, practical, and actionable product design ... Read More

DFM stands for Design for Manufacturing or Design for Manufacturability and is also sometimes referred to as DFMA, where the A represents Assembly. This manufacturing process occurs during the product ... Read More