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.