Our medical parts precision machining service offers our clients confidence in the products they receive. Confidence is a uniquely meaningful term if you are a designer or manufacturer of medical devices. We 3Q MACHINING is specialized in all different medical parts machining manufacturing. Thanks to our trusted reputation for meeting exceptional requirements for intricate and highly complex components, we deliver the supply reliability our medical customers can’t live without.
Main Materials for Medical Machining Parts
Qualifications for Making CNC Machined Medical Parts
Machining medical parts for the medical industry is not like making parts for other industries. Whereas most ordinary metal parts must meet ISO 9001 quality management requirements, medical parts must meet further standards.
According to the International Standards Organization, companies involved in the design, development, production, storage, distribution, installation, or servicing of medical parts must demonstrate their “ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”
To get your medical parts approved for use, they have to pass these standards of qualification:
- ISO 13485:This is the medical industry-specific qualification standard. It expands on the finer details of the ISO 9001 standard related to the medical industry, emphasizing the regulation of production processes. It regulates production stages such as process validation, risk management, and quality control. Compliance with this standard makes it easier for any company to bring its products to the international market.
- Precision machining to tight tolerances (as tight as 0.0001” inches for some parts): Many of these medical parts requires extra tight tolerances due to their small intended size. This applies especially to those meant for intrusion into the human body. Their small size will help to minimize intrusion and help patients heal faster. Hence, the machines used for medical instrument machining must be able to accommodate tight tolerances.