ISO 13485:2016

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ISO 13485:2016 STANDARD - TRANSITION, CERTIFICATION & AUDITOR TRAINING

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

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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.

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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.

Please write to us: info@sbsglobals.com

WHY CHOOSE ISO 13485 CERTIFICATION FROM SBS?

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.


  • 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

Please write to us: info@sbsglobals.com

To help guide you to successful certification we offer a variety of training courses to meet the requirements of any organization.Set your organization ahead of the competition with a ISO 22301 certification audit from SBS.

Please write to us: info@sbsglobals.com

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