Current Case for Quality Working Group Focus

Four Case for Quality Work Groups, whose members include  top officials from FDA and leading experts from small to large medical technology companies, are pursuing methodologies and models to inform industry design and manufacturing practices as well as agency regulatory models that will redefine and create this new culture of quality.

Their current work focuses on:

  • Maturity Model

Enable an organization to assess the capability of its quality system to reliably develop and manufacture high quality medical devices.

  • Metrics

Create well-defined, stakeholder-verified (FDA and industry) product quality metrics to predictively assess product quality.

  • Advanced analytics

Offer hospital providers information and analysis techniques to evaluate medical device quality and subsequent patient value.

  • Competencies

Construct techniques that improve competency across systems and individual functions.

More Information

Learn more about the FDA Case for Quality.