Hardware Podcasts

#420: MedTech Synergy: The Project Manager and Quality Professional Relationship

Global Medical Device Podcast · 18 Aug 2025 · 39m · Episode 420

What this episode covers

Beth Waring, a medical device consultant at Greenlight Guru, discusses the critical relationship between project managers and quality professionals, advocating for a shift from a 'police force' mentality to a collaborative partnership. She explains the distinction between 'big Q' (the department) and 'small Q' (a company-wide quality mindset), emphasizing that open communication and explaining the 'why' behind procedures are key to adoption. The conversation highlights how digital EQMS solutions like Greenlight Guru streamline design controls, change orders, and traceability, reducing the manual burden on project managers and ensuring compliance with regulations like 21 CFR Part 820 and ISO 13485.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, SPD Swiss Precision Diagnostics, Logic
Also
ISO 13485, IEC 62304, 21 CFR Part 820, ISO 14971, QMSR 2020

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