Hardware Podcasts

#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

Global Medical Device Podcast · 7 Nov 2024 · 37m · Episode 390

What this episode covers

Ashkon Rasooli, a quality and regulatory expert, joins host Etienne Nichols to outline four core principles for building an effective, non-burdensome Quality Management System (QMS) for medical device companies. Rasooli argues for 'Quality over Proceduralism,' 'Culture over Mandate,' 'Redundancy over Duplication,' and 'Conciseness over Verbosity' to ensure the QMS serves the business rather than just acting as a compliance checkbox. He advises new founders to engage quality and regulatory advisors early in the design phase to optimize architecture and avoid costly retrospective documentation. The discussion also covers the strategic decision of whether to treat quality as a minimum regulatory hurdle or a key business differentiator.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Also
FDA, ISO 13485, ISO 62304, ISO 9001

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