Hardware Podcasts

Meet a Guru: Erica Loring

Global Medical Device Podcast · 28 Oct 2020 · 38m · Episode 165

What this episode covers

Erica Loring, a medical device guru at Greenlight Guru, discusses her background in pharmaceuticals and IVDs, emphasizing the critical distinction between Quality Assurance and Regulatory Affairs. She explains how the 'throw it over the wall' mentality creates documentation gaps and costly remediation, advocating for cross-functional collaboration from concept to market. Loring highlights the importance of investing in people, allowing adequate time for development, and rigorously auditing suppliers to ensure successful product launches.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Lonza Biologics, Cook Medical, Master Control, Breathe 99, Masks On
Also
FDA, ISO 13485, 510(k), EUA

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