Hardware Podcasts

Meet a Guru: Tom Rish

Global Medical Device Podcast · 5 Aug 2020 · 29m · Episode 158

What this episode covers

Tom Rish, a senior medical device guru at Greenlight Guru, discusses his background in orthopedic implants at Zimmer and his current role helping startups navigate regulatory frameworks. He emphasizes that regulations like FDA 21 CFR 820 and ISO 13485 are simple efficiencies rather than complex burdens, advising companies to 'right-size' their Quality Management Systems (QMS) by focusing only on immediate needs. Rish shares practical advice for one-person teams and early-stage companies, such as writing procedures while performing tasks to ensure they are efficient and avoiding the 'procedure overload' that leads to non-compliance. He highlights the importance of integrating documentation, like risk matrices and user needs, into the daily workflow to prevent last-minute 'non-stop paperwork' crises before submissions or audits.

Most relevant to

founders before launch and early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Zimmer
Products
Greenlight Guru MDQMS
Also
Purdue, FDA, ISO 13485

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