Relevant device manufacturer certifications vs non relevant resin certifications

Cutting corners by using non relevant "certifications" of raw materials suppliers, instead of certifying your company, your own medical devices, and your own manufacturing processes will not cover you legally since you will always be responsible of the quality and safety of the products manufactured in your facility. No one can cover your back from malpractice, nor can replace your responsibility as manufacturer.

Consequently, reliance on non valid non relevant certifications does not provide any legal coverage nor warranty since the safety and quality of any 3D printed device obviously legally relies on the device manufacturer, not on its raw material / 3D resin suppliers.

Biomedical device manufacturers are responsible of working with well designed and implemented manufacturing practices, processes, protocols and quality controls, which should ensure maximum polymer conversion and minimum content of leachables, extractables, residuals, impurities and byproducts of their produced medical devices.