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The Food and Drug Administration1 (21CFR 820.30) defines Design Controls as:

“A set/framework of quality practices and procedures incorporated into the design and development process of a medical device product to assure that device specifications meet user needs and intended use(s)”.

Design controls enable integrating a systemic approach to design during the product development lifecycle to:

  • Proactively identify gaps in design input requirements (as early in the lifecycle as possible)
  • Recognize discrepancies between the proposed designs and requirements

With early correction of designs, rework can be minimized, costs kept under control, and resource allocation improved. This ensures the performance, quality and regulatory requirements of the product are met. It also helps increase design conformance to user needs while improving collaboration and coordination between the different stakeholders.

In this whitepaper, we talk about:

  • How design controls help in designing a safe device
  • How design controls is linked to the product development lifecycle
  • Common challenges with design controls
  • Cloud-based design controls solution from ComplianceQuest
  • And more

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