Hardware Podcasts

071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols

Let's Combinate · 8 Feb 2023 · 59m

What this episode covers

Etienne Nichols, host of the Global Medical Device Podcast and Medical Device Guru at Green Light Guru, discusses his transition from the steel industry to MedTech and his work on combination products. He emphasizes that document control (21 CFR 820.40) is critical for preventing costly errors, illustrating this with an anecdote about saving a $100,000 steel coupling from being scrapped due to a decimal error. Nichols argues that management responsibility is the most important quality system element, as it sets the cultural tone for prioritizing quality over speed, and highlights the importance of strong purchasing controls to ensure quality flows to contract manufacturers.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Green Light Guru, Baxter, Motorola, Kodak, UL, J and J
Products
Global Medical Device Podcast
Tools
SolidWorks
Also
John Spears, Mike Drews, Skip Krebling, 21 CFR 820, ISO 13485, ICH, ASQ, Kevin Becker

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