Medical Injection Molded Products
Plastic injection molding for medical products has proven to be a cost-effective and reliable process that medical manufacturers of all kinds have embraced. Although the process seems simple on the surface, dig underneath a bit and you’ll soon find that manufacturing plastic medical products, parts, and components is full of opportunity for error – and in the medical field, errors can literally be deadly.
To minimize the risk of error or product failure, the factors listed below must be considered when selecting your plastics manufacturing partner.
Both the U.S. and Canada have strict regulations regarding cleanliness and sterility for medical devices. These requirements apply to the products and their component materials as well as the manufacturing process itself. Any manufacturing facility should, at a minimum, meet those standards and undergo regular audits and inspections to receive medical-grade approvals to ensure continued compliance. Baytech Plastics is proud to be NSF Certified and in full compliance with all applicable U.S. and Canadian regulatory requirements related to plastic injection molding for medical products.
ISO certification and compliance.
Another regulatory certifying body is the International Organization for Standardization (ISO). ISO is an independent, non-governmental organization that shares expert knowledge across industries and around the world to create “world-class specifications for products, services and systems, to ensure quality, safety and efficiency”. ISO registered facilities, like Baytech Plastics’ two plastics manufacturing facilities, ensure that “products and services are safe, reliable and of good quality.”
Products are only as good as the materials used to make them. The raw materials used in the production of medical devices must meet specific criteria and exhibit certain properties in order to be used in medical device manufacturing. They should: