Mastering Standards Management: Traceability & Reuse in Medical Device Development

Описание: ---In Episode 3 of Lunch with Larry, we dive into one of the most critical, but often overlooked, elements of design control: standards management.

Learn how to create a centralized reuse library that connects external standards (like ISO 60601, 62366, or FDA guidelines) to your normative documents and project requirements, enabling instant traceability and faster regulatory submissions.

In this video, Larry covers:
How to structure external standards into atomic work items.
How to build a hub-and-spoke model for standard reuse.
How to track revisions, traceability, and compliance with just a few clicks.

Why most companies struggle with this—and how to fix it with better tooling
The business case for reuse: reducing risk, improving audit outcomes, and saving time

This session is essential for:
✅ Regulatory Affairs Professionals
✅ Quality Systems Engineers
✅ Product Developers in Regulated Industries
✅ Anyone working with FDA, ISO, or IEC standards in medical device design

📈 Stop managing standards manually—start leveraging them strategically.

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📩 Contact Larry: [email protected]
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Fox Solution US LLC
Laurence Sampson, President
Website: www.foxsolutionus.com
Laurence Sampson LinkedIn:   / laurencesampson  
Email: [email protected] Add to Subject the word "request"
Contact Phone: +1 (303) 345-3616

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