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Archimedic Blog

The Latest MedtechĀ Insights from Archimedic.

Investigational Device Exemption (IDE) Trials: Burden or Asset? alex shaw clinical strategy regulatory strategy Jul 16, 2026

Are Investigational Device Exemption (IDE) trials a burden or asset?

Truth is, they can be either, depending on how they're designed.

Ask most device teams about IDE trials, and you'll hear about bu...

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Crossing the Chasm from QSR to QMSR alex shaw quality management regulatory strategy Jun 23, 2026

Are you adapting an existing quality system from QSR to QMSR/ISO 13485?

If so, you're not alone, and you may be finding that the transition isn’t completely seamless.

To bring everyone up to speed, ...

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Is It a Medical Device? alex shaw product development regulatory strategy Jun 17, 2026

Is your product a medical device…or is it not?

It is a seemingly simple question. However, we often talk with innovators who are unsure about the answer.

The ramifications are real, and often existe...

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The Importance of Core Values alex shaw team development May 28, 2026

Should a small BioTech or MedTech startup spend precious time and resources developing a corporate mission and core values? The answer is 100%, absolutely, unequivocally, YES.

A clearly stated missio...

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