Introduction:

ISO 13485:2016 is an international standard that specifies requirements for a quality management system for organizations involved in the design, development, production, installation, and servicing of medical devices. As an accredited certification body by EGAC, iCAA can help organizations achieve certification to ISO 13485:2016.

Benefits:

The benefits of ISO 13485:2016 certification include improved product quality, increased customer satisfaction, enhanced regulatory compliance, and reduced costs and risks.

Certification Process:

The certification process involves several steps, including an application, a documentation review, an on-site audit, and issuance of the certificate. The audit process includes a review of the organization’s quality management system, as well as an assessment of its compliance with regulatory requirements.

Maintaining certification requires ongoing compliance with the standard and periodic surveillance audits to ensure continued compliance.

Key requirements of ISO 13485:2016 include a focus on risk management, product realization, process validation, and control of nonconforming products. The standard also emphasizes the importance of customer feedback, product traceability, and continuous improvement.

iCAA. Accredited Scopes from EGAC

• MD QMS – ISO 13485 (in accordance with IAF MD 9:2023 Issue 4, Version 2)
  • Non-active Medical Devices
    • General non-active, non-implantable medical devices
    • Non-active implants
    • Devices for wound care
    • Non-active dental devices and accessories
    • Non-active medical devices other than specified above.