Processing medical parts for the medical industry is different from manufacturing parts for other industries. Most common metal parts must meet ISO 9001 quality management requirements, while medical parts must meet more standards.
According to the regulations of the International Standards Organization, companies involved in the design, development, production, storage, distribution, installation or service of medical components must demonstrate that they are "capable of providing medical equipment and related services that consistently meet customer and applicable regulatory requirements."
In order for your medical components to be approved for use, they must pass the following eligibility criteria:
ISO 13485: This is a specific qualification standard for the medical industry. It expands to more details of the ISO 9001 standard related to the medical industry and emphasizes the supervision of the production process. It regulates the production stages, such as process verification, risk management and quality control. Compliance with this standard makes it easier for any company to market its products to the international market.
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