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Medical Device Design Controls: Definition, Requirements, Process, Flow Chart, Phases, and Examples Scottsdale

Published date: November 28, 2025
  • Location: Scottsdale, Arizona, United States

At Arterex Medical, design controls form the foundation of safe, effective, and compliant medical device development. Design controls are a structured set of practices required by regulatory bodies such as the FDA (21 CFR 820.30) and ISO 13485 to ensure medical devices consistently meet user needs, intended use, and regulatory expectations. They guide product development from concept to commercialization while reducing risk and ensuring quality. For More Information Visit: https://arterexmedical.com/medical-device-design-controls/


Please visit our website: https://arterexmedical.com/
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