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The Device Files: From Concept to Commercialization · Aug 26, 2026

Building a Claims System: Matrix, Review Board, and Standard Operating Procedure

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Blythe Karow · The Device Files: From Concept to Commercialization

Marketing claims matter. They matter a lot when you’re a medical device and they still really matter when you’re not a medical device. This guide can be used by either type of company.

Companies can get in trouble if they can’t substantiate their marketing claims, so having a system in place to control your advertising risk is prudent.

This guide will go over three pieces of the puzzle:

  1. Establishing Standard Operating Procedure and training your organization to use it.

  2. Creating a Claims Matrix to document and hold a central source of truth.

  3. Convening regular document review committees to have internal alignment on proper wording for new marketing.

Read the original on blythekarow.substack.com

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