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ISO 13485 certification from SGS helps you achieve approval, sell your devices more effectively and reduce the number of supplier audits.

Medical device

The ISO 13485 standard, currently ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, sets the basis for a quality management system for organizations involved in the life-cycle of a medical device. Certification demonstrates your commitment to meeting your customers’ requirements and supports regulatory compliance in many jurisdictions.

Our wide range of regulatory approvals, our United Kingdom Accreditation Service (UKAS) accreditation and close links with medical authorities enable us to meet your certification requirements effectively. For many markets, ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices. With a strong reputation for certification, we have the expert knowledge and global networks of auditors to help you achieve your objectives.

Why Choose ISO 13485 Certification from SGS?

We offer a global service for UKAS accredited ISO 13485 certification. Our worldwide presence means your audit will normally be carried out by local-language auditors.

We can help you:

  • Gain UKAS accredited ISO 13485 certification 
  • Demonstrate your commitment to meeting your customer requirements 
  • Comply with regulations and gain the additional local regulatory certification you need to manufacture and sell medical devices

ISO 13485:2016 is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.

We can also help you build strong foundations for your medical devices certification strategy with our UKAS accredited ISO 13485:2016 audit, supporting regulatory approvals globally.

How Can SGS Help?

We provide a wide range of solutions to help you to stay on top of the latest developments and ensure a smooth and transparent transition from your current ISO 13485:2003 certification. We also offer awareness, lead auditor and internal auditor training courses to help you to understand the requirements of ISO 13485:2016 and risk-based thinking.

Transitioning to ISO 13485:2016

Existing certification to ISO 13485:2003 and EN ISO 13485:2012 will remain valid until the end of the transition period March 31, 2019.

To discuss your ISO 13485 certification requirements, contact us today.