ISO 13485: Medical devices – Quality management systems requirements for regulatory purposes

Hence, the supplier or the external party can voluntarily choose to conform to the requirements of this ISO 13485 certification or can be required to contract to conform. The exact definition and understanding of this ISO 13485 certification differs from nation to nation and region to region. The important thing to be noted is that the concerned organization must need to know how such definitions related to the ISO 13485 certifications will be interpreted in light of the regulatory definitions in the jurisdictions in which the medical devices are made available. The other thing that is made into consideration is that the Quality management system (QMS) specified in the ISO 13485 certification are complementary to the technical requirements for products that are necessary to meet customer and also the applicable regulatory requirements for safety and performance.

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