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ISO 13485 Certification

Fulfil Quality Management System Requirements according to standards like ISO 13485

In order to create a management system that ensures constant quality of medical devices and related services, companies that manufacture, distribute or participate in the manufacture of medical devices need to fulfil the requirements set in ISO 13485.

The benefits of Auditing (ISO 13485)

  • Fulfil all the Management System requirements set in ISO 13485

  • Develop a Management System that delivers consistent quality components, finished products or services

  • Proof of compliance with all the relevant Management System guidelines

  • Increased efficiency and reduces business risks

  • Can facilitate progression towards some market authorizations

Management Systems Auditing and Certification

About Auditing (ISO 13485)

In order to ensure constant quality of medical devices and related services, our customers need to fulfil the requirements set in ISO 13485, which specifies the Management System requirements that an organization needs to fulfil to have robust processes for the development, production, design, and servicing of medical devices and in vitro diagnostic medical devices.

ISO 13485 is a recognized and harmonized standard derived from ISO 9001 and specifically developed for medical device companies. ISO 13485 is the basis for the certification of quality management systems (QMS) in companies that manufacture, distribute medical devices or participate in their manufacture as part of the supply chain.

DEKRA’s specialists check, assess and certify the compliance with the requirements set in ISO 13485, which benefits all companies that manufacture or distribute medical devices or somehow participate in their manufacture as part of the supply chain. The audits that are carried out against ISO 13485 determine the degree of fulfillment of such organizations with respect the Quality Management System requirements specified by the standard.

DEKRA offers a wide certification portfolio in addition to ISO 13485, including other schemes valuable to the Medical Device industry such as ISO 45001 and ISO 14000 series, as well as client processes certification schemes (not accredited) according to EN ISO 11135, EN ISO 11137 and EN ISO 17665 (Ethylene oxide sterilization, radiation sterilization and steam sterilization).

Our experts ensure that the Management System of DEKRA’s healthcare customers are certified according to the quality system and regulatory requirements.

DEKRA offers our healthcare customers the following benefits:

  • Proof of compliance with the relevant Management System guidelines for the manufacturing and distribution of medical devices
  • Increased efficiency
  • Lower risks
  • Easier access to new markets
  • Competitive advantages and winning new customers

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