ISo 13485 certificering • Læs om fordelene ved denne standard

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Become certified by ISO 13485 Medical Equipment

Bureau Veritas Certification Denmark A/S

All organizations today face challenges in following the law requirements for medical devices. The International Standard ISO 13485 specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

The requirements in this standard can also be used by suppliers or other external parties providing product (e.g., raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this standard or can be required by contract to conform.

The Benefits of an iso 13485 certification

Help to fulfill the regulatory requirements: Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, this standard helps the organization to define its role and its quality management system in relation with the expected requirements.
The process approach: For an organization to function effectively, it has to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome is an effective manner to structure and set a process for improvement.
Allow the standardization of the medical device industry and related services: the requirements are applicable for organization regardless their size, their type, and their activities in relation with medical device or associated services for a better communication within the medical device industry world wide.
Stay updated: A new EN ISO 13485 standard amendment is expected in Europe with the integration and the MDR and IVDR requirements. This new version with facilitate the application of the two new regulatives into the company quality management system.

ISO 13485-standard contribute to the World Goals, Bureau Veritas

The ISO 13485-standard contributes to the goals of the UN

The 17 goals of the UN are globally acknowledged and essential to achieve a sustainable development.

To succeed with the world goals of the UN it takes a whole lot of engagement from business communities, individuals, industries and governments. Here the international acknowledged guidelines, the ISO-standards, play an important role, as they are built upon consensus and provide a basis for which direction the development should take. Because of this, the standards make it possible for all the involved parts to move within the same direction.

According to ISO - International Organization for Standardization, the ISO 13485-standard contributes to the following world goals: 3 and 10.

training in ISO 13485

Find relevant training in ISO 13485 for implementing and maintaining an ISO 13485 medical equipment management system. Find the training by clicking on the link.