We’re proud to serve a wide range of industries with our injection molding technology at EnviroTech Custom Injection Molders, and one we take particular pride in is medical equipment manufacturing. Plastic injection molding is an important process used for many medical devices, including products like filtration plates, equipment housings and various bed frame and other components.

This is also an area that requires detailed documentation and precision among manufacturers, natural given the serious nature and use of such products in a medical setting. For any medical company interested in our services, we’re happy to detail the wide range of specific practices we undergo to produce approved, high-quality medical equipment. This two-part blog series will go over a number of requirements for plastic injection molders within the medical device industry so clients can be assured of high-quality parts.

FDA Registration Requirements

First and foremost, manufacturers like us must register with the Federal Drug Administration (FDA) to be qualified to produce medical-grade equipment for companies. To meet the requirements for registration here, all such manufacturers must have a Quality Management System in place.

This system details the facility’s daily operations in several areas. It’s covered by the 21 code of Federal Regulation 820, which includes medical devices. Any component that’s distributed to a finished-device manufacturer, or devices packaged or labeled for commercial distribution of health-related purposes, falls under these guidelines.

Specification Restrictions

In addition, parts manufacturers will have several restrictions placed on specifications to ensure they meet all health and safety regulations within the industry they are producing products for. These restrictions may cover several areas, from acceptable resin materials for a given product to chemical resistance, thermal resistance, antimicrobial properties and numerous others. Depending on your precise industry, our manufacturers will go over restrictions present for our products.

ISO 13485

This term, which is actually ISO 13485:2003, refers to an important certification in this realm. It means the manufacturing facility in question maintains the proper procedures and documentation areas for a given manufacturing process, including themes like risk management, loss traceability and others.

Generally speaking, components and devices within this certification are classified into three separate FDA classes: Class 1, Class 2 and Class 3. Which is chosen is determined by several critical risk factors that will be evaluated by the manufacturer for the component or device, and each class here will come with different levels of regulation or compliance required. Our team will be happy to detail the basics on each of these classes if you’re unsure or require more information.

For more on any of our medical equipment molding, or to learn about our plastic injection molding services, speak to the staff at EnviroTech Custom Injection Molders today.