Global Medical Device Podcast Powered By Greenlight.guru

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 creatively interpreted for the virtual world of software development, where apps update weekly and cloud-based systems evolve in real-time. The conversation zeroes in on the often-muddy areas of production and service provision (Clause 7.5), emphasizing that these clauses are far from non-applicable, requiring a "virtual manufacturing space" mindset.A significant focus is placed on the Software of Unknown Provenance (SOUP), treating these building blocks as purchased components that require robust supplier evaluation and validation, bridging Clause 7.5 (production) with Clause 7.4 (purchasing). The discussion extends to crucial concepts like the Software Bill of Materials (SBoM), the complexity of Agile vs. Waterfall approaches within