Design Controls

Critical to Quality

We define “Critical to Quality,” or CtQ, as a product, service or process characteristic that is quantifiable and measurable, and that has been determined to be essential to a device’s quality, per the medical device quality definition.  CtQs do not correct quality issues or act as a replacement for sound technical judgment or sound financial discipline.

Identifying and properly characterizing CtQs ultimately should result in higher quality products and services, as well as optimized costs and speed to market. Some of the benefits to be realized can include:

  • CtQs bring a disciplined approach to a quality score card that measures quality prior to product launch and identifies critical quality elements.
  • Capturing CtQs early in the product development lifecycle provides a traceable body of knowledge, right from the initial voice of the customer on the need for a product through to the final delivery of that product.
  • Focusing on CtQs also can result in cost savings in development as product development teams can allocate activity to the most important aspects of the product.
  • Speed to market is significantly improved. Applying focus where it is needed should help avoid the need to re-work any elements due to a lack of understanding of CtQs.

About Design Controls

The first entry in AdvaMed’s Library of Successful CtQ Practices is on design control CtQs. Design control CtQs are intended to identify the practices, processes, and cultures required to effectively manage the design and development of new or existing medical devices. It explains how the CtQs fit into a product’s lifecycle and how they align with 21 C.F.R. Part 820, Essential Design Requirements, and FDA’s QSIT Inspectional Guidance. 

There are 11 presentations included that illustrate the successful practices currently used by AdvaMed member companies, along with appendices that provide more detail on specific aspects of design control (such as obtaining “voice of the customer” requirements and translating these requirements into CtQs).