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ISO 13485:2016 Certification

ISO 13485:2016 is applicable only to manufacturers’ insertion devices on the market in Europe. For the rest of the world, ISO 13485:2016 remainders the applicable standard.

The European standard ISO 13485:2016 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, have been available, after approval by CEN on March 2016. This replaces ISO 13485: 2016. The change was prepared as a number of European countries objected to the implication that ISO 13485 inferred compliance to the Medical Device Directive (MDD). To solve this problematic, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive.

Our Notified Body (GMP Certificate.com) states that once ISO 13485:2016 is harmonized there will be no need for current customers with ISO 13485 certificates to suffer an automatic update or rerelease of certification. This is because there is no change in the requirements of the standard. Any existing certificates being renewed or re-released to support changes after this date will be updated at the point of rerelease to also refer to ISO 13485:2016.

GMP-Certificate.com has extensive, global experience in the medical industry, both in management systems certification and in product safety testing and certification. We are completely accredited to suggestion third-party certification to the ISO 13485 standard. Our staff members have many years of industry experience, and they work directly with regulatory authorities to stay updated on the latest requirements - resulting in a wealth of knowledge that we are capable to pass on to you.

ISO 13485: 2016 is an international standard that signifies the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not necessity to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485: 2016 applies to the design, installation, development, manufacture and servicing of medical devices. Compliance is a measure of your capability to meet customer and legal requirements.

Benefits of ISO 13485

  • Increases efficiency
  • Signal of reliability for your stakeholders
  • Tool to ensure your business’s continuity
  • Increases risk management and reduces risks
  • Tool to develop management activities
  • Tool to involve staff through risk management

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