Cookie consent(s)
We use cookies to personalize content and ads, provide social media features, and analyze traffic. This is done only with your explicit consent. By clicking "ACCEPT ALL," you agree to the processing and sharing of your data with our partners for social media, advertising, and analytics, including in third countries in accordance with Art. 49(1)(a) GDPR and Art. 17(1)(a) FADP (Switzerland). There is a risk that your data may be monitored by authorities without legal recourse. You can change or revoke your consents at any time in the data privacy settings .
Data protection declaration | Legal notices
Settings

ISO 13485 Certification

Quality Management System

ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for organizations involved in one or more stages of the life-cycle of a medical device and describes a process approach in terms of the design, safety and quality.

  • ISO 13485 certification shows that an organisation has successfully met the requirements of this standard. In addition to facilitating supplier validation, this certification is increasingly considered to be the basis for market authorisations of medical devices, including CE and UKCA marking.
  • Evidences a manufacturer's commitment to quality by the objective assessment of products, processes and services.
  • Documents compliance according to the relevant standards for manufacturing of medical products.
  • Meets major industry requirements from legal manufacturer's through to component manufacturer's feeding into the pipeline.
  • Can be delivered in combination with other schemes such as MDSAP, CE marking and/or UKCA marking through DEKRA's one-stop approach to medical service delivery.
DEKRA’s audit team consists of experts with extensive skills and expertise to accurately assess the compliance of your management system according to ISO 13485.
Download
Program Requirements QMS Auditing Services
Program Requirements QMS Auditing Services