Processes for the production of medical injection molded parts as well as downstream processes such as assembly can be validated.
For products used in the medical sector, current regulations require detailed documentation during the entire process planning and production phase. Specifically, they state that production processes whose results cannot be verified must be validated.
However, the search for a "one-fits-all" recipe is in vain. This is because validation is process-dependent and is determined by a large number of process-related variables. Anyone who wants to manufacture plastic components and place them on the market ("inverkehr") must therefore develop a suitable approach themselves, provide verifiable documentation and keep this process up to date at all times.
This is where the services of Novoplast Schlauchtechnik and Fleima-Plastic come in: In addition to the manufacturing processes of injection molded parts, downstream processes such as assembly can also be validated in accordance with standards.
We support distributors with process validation
Novoplast Schlauchtechnik and Fleima-Plastic, the two medical technology brands of the Masterflex Group, support manufacturers and distributors of medical products with validation.
