Episode 26 - The ISO 13485 Standard

In this episode of the Quality Hub podcast, host Xavier Francis engages ISO experts Murphy Shaw and Matthew Pilley, consultants at Core Business Solutions, in a discussion centered around ISO 13485, a critical standard for medical devices. Murphy and Matthew emphasize the rigorous controls and risk management inherent in ISO 13485. They clarify that the standard applies not only to manufacturers of implantable devices but also to various healthcare industry players, from software providers to equipment suppliers. The implementation of ISO 13485 is underscored as pivotal for traceability, reliability, and consistency in medical device production. It also can significantly impact a company's reputation, compliance, and operational efficiency. Success stories of clients achieving ISO 13485 certification highlight the transformative power of the standard.

Helpful Resources:

ISO 13485:  https://www.thecoresolution.com/iso-13485

For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015

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ISO 9001 Standards: https://www.thecoresolution.com/iso-90012015-standard-1

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