ISO 13485

ISO 13485 is an internationally recognized standard that outlines the requirements for a QMS in the medical devices industry. It is designed to ensure that medical devices are safe and effective for their intended use.

Benefits of ISO 13485 certification:

ISO 13485 certification offers numerous benefits, including:

  • Compliance with regulatory requirements: ISO 13485 certification helps organizations comply with regulatory requirements, such as the EU Medical Devices Regulation (MDR) and the US Food and Drug Administration (FDA) Quality System Regulation (QSR).
  • Improved product quality: ISO 13485 certification helps organizations improve product quality, leading to increased customer satisfaction and loyalty.
  • Risk management: ISO 13485 certification requires organizations to identify and manage risks associated with their products and processes, reducing the likelihood of product failures and recalls.
  • Competitive advantage: ISO 13485 certification gives organizations a competitive advantage, helping them stand out from their competitors and win new business.

Our ISO 13485 certification services:

We offer a comprehensive range of ISO 13485 certification services, including:

  • Gap analysis: We will conduct a thorough review of your existing QMS to identify any gaps and areas for improvement.
  • Implementation support: Our team of experts will guide you through the implementation process, providing support at every stage to ensure that your QMS meets ISO 13485 requirements.
  • Internal audit: We will conduct an internal audit to assess your QMS and identify any non-conformances that need to be addressed before the certification audit.
  • Certification audit: Our team of auditors will conduct an on-site audit to assess your compliance with ISO 13485 requirements and determine whether to grant certification.
  • Surveillance audit: We will conduct regular surveillance audits to ensure that you maintain compliance with ISO 13485 requirements.
  • Re-certification audit: We will conduct a re-certification audit every three years to ensure that your certification is up-to-date and reflects your ongoing commitment to quality management.

Our approach:

We take a practical and collaborative approach to ISO 13485 certification, working closely with you to understand your organization’s unique needs and risks. Our team of experts will guide you through the certification process, providing support at every stage, from initial consultation to final certification.

Contact us:

If you are interested in achieving ISO 13485 certification, please contact us for a free consultation. Our team of experts will be happy to answer any questions you may have and provide you with a customized quote for our services.