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#436: Do ISO 13485's Production Controls apply to SaMD? artwork
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#436: Do ISO 13485's Production Controls apply to SaMD?

Global Medical Device Podcast powered by greenlight.guru by Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory

Dec 8, 202543:05Business

This episode tackles the complex challenge of applying the hardware-centric clauses of ISO 13485 to Software as a Medical Device (SaMD) . Adnan Ashfaq, founder of Simply Medica, joins Etienne Nichols to dissect how tradi...

About This Episode

#436: Do ISO 13485's Production Controls apply to SaMD? is an episode from Global Medical Device Podcast powered by greenlight.guru by Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Qua...

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Episode Details

Published Dec 8, 2025, 43:05 long, audio available.