Software as a Medical Device (SaaS / SaMD)

Software as a Medical Device (SaaS / SaMD)

Quality Systems Now
Published on: 04/06/2026

Software now performs functions that were historically limited to physical medical devices, laboratory instrumentation, or direct clinical assessment.

News
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Case Study SaMD and IVD Medical Device Start-Up

Case Study SaMD and IVD Medical Device Start-Up

Quality Systems Now
Published on: 07/01/2026

This case study illustrates how targeted ISO 13485 support can enable a SaMD and IVD medical device start-up to establish robust, compliant quality systems and achieve audit readiness.

Medtech
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