Hardware Podcasts

Meet a Guru: Wade Schroeder

Global Medical Device Podcast · 19 Aug 2020 · 26m · Episode 160

What this episode covers

Wade Schroeder, an electrical engineer and medical device guru at Greenlight Guru, discusses his background in IVD and product development, emphasizing the importance of early risk management and robust design inputs. He shares insights on helping startups navigate FDA design controls, citing examples of companies pivoting for the opioid crisis and COVID-19 while maintaining rigorous quality systems. Schroeder advises engineers to record and rationalize all decisions to ensure compliance and facilitate future audits or design changes. The conversation highlights Greenlight Guru's 'Guru Edge' of leveraging experienced professionals to mentor clients through complex regulatory landscapes.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru
Also
Wade Schroeder, John Spear, IEC 610, 21 CFR 820, FDA

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