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Combination Products and ISO 13485

  • 1.  Combination Products and ISO 13485

    Posted 2 hours ago

    Hi, Exemplar Community:

    I would like to know how many of you work in the combination product arena and how you establish and implement a monitoring system to ensure that post-market quality surveillance complies with ISO 13485, specifically within a pharmaceutical-industry-centric QMS.

    I spent most of 2025 designing an ISO 13485-compliant sub-QMS process for the combination product and successfully implemented the processes prior to FEB 2026. The system and records have not been inspected by the Health Authority; therefore, I would like to know if your company has already been inspected for the combination product-specific requirements.

    Thank you.

    Ming (Device and Combination Product Quality Oversight)



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    Ming Aquila
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