Top 3 Must-Haves When Getting Any Medical Components Made

The manufacture of components for medical equipment is governed by the FDA. Medical equipment manufacturers must be registered and the devices they manufacture specifically listed.

Every care has to be taken to ensure a medical component is hygienic, safe and suitable for performing the task it was designed to do. As part of this process, manufacturers need to implement a rigorous quality management system that ensures parts manufactured comply with specifications, are traceable and properly documented. Three must-haves are cleanliness, precision and finish.

Cleanliness

The production processes must ensure components are kept clean and hygienic. In order to deep draw components, it may be necessary to use special lubricants and it’s possible that small quantities of hydraulic fluid may be present. So in order to ensure proper cleanliness, all fluids used must be safe and special cleaning processes used to remove all traces of fluids and manufacturing debris that remain after manufacture. After cleaning, components need to be carefully packaged to prevent contamination.

Precision

The manufacturing process must have the capability to make parts to the exact specifications. Whether parts are to be used in medical equipment or for implant, manufacturing tolerances must be maintained to ensure the components will fit precisely and work as intended. There should be no surface defects and the deep drawing process carefully monitored to ensure that the required part thicknesses are achieved and that overall dimensional stability is maintained.

Surface Finish

One of the best methods of ensuring a medical component is hygienic is to specify a very high-quality surface finish. Highly polished surfaces with no defects can be readily sterilized and there’s nowhere infection can take hold. It is important to make sure that tools and dies used have a good surface finish and are well maintained so that parts coming off the press have high-quality internal and external finishes and that subsequent finishing processes readily achieve the specified finish.

Choose the Right Medical Component Supplier

Accurate Forming has been manufacturing first-class deep drawn products since 1955. As a well established manufacturer of deep drawn medical components, Accurate Forming is able to manage complex projects on a turnkey basis, including management of outside suppliers. Our quality assurance program complies with rigorous ISO 9000: 2008 requirements and we are able to manufacture components in all metals that are medically compatible. If you need deep drawn medical components manufactured, contact us and assess our abilities.