Plastic injection molding companies provide products and services to a variety of clients. Products commonly demanded by the medical industry are medical instruments. Unlike the standard plastic injection process, the medical plastic injection molding goes above and beyond. This type of plastic injection molding service is not simply a matter of plastic materials, the mold, and the right machinery—but is also about achieving the high standards set by ISO.
ISO Standards and Quality Control
We understand how important is it to both meet and uphold ISO’s high standards. At MDI, we focus on two particular aspects:
- Quality Control Capabilities
- Operational Controls
When producing medical devices, it is essential to make certain that the conditions, the environment, the molds, the molding equipment, and the material conform to and comply with the ISO quality system. In order to meet these standards and exceed them, a company who offers plastic injection molding services must have a highly controlled product system that documents when it arrives to when it is shipped. For example, ISO-13485 states that if either your equipment or control system fails to meet the ISO standards for medical devices, the material produced will not be useable. Therefore, in order for a company to provide this type of high-quality, medical plastic injection molding, it must have annually renewed certification that meets specific ISO standards.
Clean Room Assembly
Another large factor in the medical injection moldings process is the environment. In order for a plastic injection molding company to produce high-quality products that abide by ISO standards, they usually need a clean room in place. The company must also receive clean room certification prior to claiming its ability to produce ISO certified plastic injection molded medical devices.
In a clean room, it is necessary to make sure that the particle count levels are below acceptable standards. Failure to do so can result in revocation of the certification, and more importantly, clients’ expectations, specifications, and requirements will not be met.
Choosing the Right Plastic Injection Molding Service
When it comes time to choose the right company for medical plastic injection molding, make certain to choose a company who complies with ISO standards. At MDI, we have the technology, the capabilities, and the certification to meet and exceed the specifications of all our clients. We work with them to ensure that they receive the type of plastic injection molding service necessary to produce a high-quality, durable, and cost-effective product.