ISO 13485
ISO 13485 is an internationally recognized quality management system (QMS) standard for the medical device industry. It applies to organizations involved in one or more stages of the medical device lifecycle and outlines a process-based approach to ensuring safety and quality, from design and development to manufacturing and servicing.
Key Features of ISO 13485 Certification:
• Third-party certification provides objective evidence that your quality management system conforms to the requirements of the standard. In addition to enhancing trust among business partners and suppliers, it also helps build a strong foundation for access to international markets, including CE certification.
• Through assessments covering products, processes, and services, organizations can clearly demonstrate their commitment to quality with documented procedures and records.
• It becomes easier to organize and document compliance with the various standards and requirements related to medical device manufacturing, helping strengthen ongoing quality control.
• The standard covers practical requirements that can be applied across the entire medical device supply chain, from legal manufacturers to component suppliers and contract manufacturers.
DEKRA’s audit team consists of experts with extensive knowledge and industry experience in management system assessments based on ISO 13485. By taking into account each client’s business operations and product characteristics, we accurately assess conformity and support a smooth certification process.
In addition, DEKRA helps reduce the audit burden on clients by offering combined audits with other standards and schemes, such as MDSAP and CE certification, through a one-stop service approach. With efficient audit planning, clients can move more smoothly through the certification process.
In addition, DEKRA helps reduce the audit burden on clients by offering combined audits with other standards and schemes, such as MDSAP and CE certification, through a one-stop service approach. With efficient audit planning, clients can move more smoothly through the certification process.