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ISO 13485:2012 Certification

EN ISO 13485:2012 is applicable only to manufacturers placing devices on the marketplace in Europe. For the rest of the world, ISO 13485:2003 remains the applicable standard.

The European standard EN ISO 13485:2012 Medical Devices, Quality Management Systems, Needs for Regulatory Purposes, has been published, after approval by CEN on 24 January 2012. This replaces EN ISO 13485: 2003. The change was made as a number of European countries objected to the inference that ISO 13485 inferred compliance to the Medical Device Directive. To solve this difficulty, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive.

ISO 13485 is based on the ISO 9001:2008 procedure model approach and is a management systems standard particularly developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory needs.

ISO 13485: 2012 is an international standard that represents the needs for a comprehensive excellence management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory needs, an organization does not require to be actively manufacturing medical devices or their components to look for certification to this standard. ISO 13485: 2012 applies to the design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet client and legal needs.

The EN ISO 13485:2012 certification was awarded by the International Organization for Standardization, the world's major developer and publisher of worldwide quality and safety standards. This certification outlines exact necessities to establish and execute a structured quality management system for medical devices across all areas, from development to supply.

Benefits of ISO 13485: 2012 Certification

  • Adds simplicity to the way complaints, surveillance or product recalls is handled.
  • Decrease operational costs by highlighting procedure deficiencies and improving effectiveness.
  • Access to markets that identify or require the certification including Canada and Europe.
  • Enhance client satisfaction by consistently delivering quality products and systematically addressing complaints.
  • Proven commitment to excellence through a globally recognized standard.