#404: MedTech 101: What You Need to Know About the Medical Device Industry

#404: MedTech 101: What You Need to Know Abou...

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

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 traditional standards intended for physical manufacturing must be ...  Afficher plus

#435: ICYMI (In Case You Missed It!) Becoming a Regulatory Affairs Professional

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs profession ...  Afficher plus

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