Posts tagged quality management system
Product Design & Development: Regulatory and Standards Overview

Medical device regulations require information to be recorded as you develop; this includes how the design was created, why design decisions were made, and what risks were considered in the process. Here is a basic outline to get you started.

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Quality Management: What Product Startups Need to Know

Maren Nelson, a PMP-certified, medical device consultant for Product Creation Studio talks to startups on how they can establish informal documentation from the start, examples of accepted criteria and three guiding principles of any quality management system.

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