From the Helm Webinar

Online Design Controls

What is the best way to approach design controls?


This is an essential question medical device organizations need to answer before embarking on any new project. Because 21 CFR 820 requires quality systems to undergo structured design procedures, product development teams should have measures in place to satisfy them.

In “A Guided Approach to Design Controls”, part of the From the Helm webinar series from Cognition Corporation, CEO David Cronin walks viewers through methods for satisfying design controls. Advocating a unified system to manage SOPs, content, and deliverables, Mr. Cronin dives into achieving compliance and maximizing effectiveness in product development.

This half-hour webinar covers the following topics:

  • Guiding users through the process—figuring out why, how, and when to complete design controls activities
  • Utilizing trace matrices, audit logs, and dashboard views to manage workflow and requirements
  • Defining risk management activities and the resulting controlling requirements
  • Verification & Validation activities, including test steps, execution, test failure analysis, etc.

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