IEC 62304 for Medical Device Software

  • Instructor :  Nancy Knettell
  • Level : Intermediate
  • Study time : 64 Minutes
  • Course ID:  TF2845
  • Included in Subscription Pack
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ABOUT THE COURSE

Are you confident your software documentation meets IEC 62304 standards?
Have you prepared the right work products to prevent a 510(k) delay or denial?
Is your team fully aligned on what’s required before submission—or at risk of a costly redo?


This session gives you a real-world roadmap to make your software submission bulletproof—before the FDA or auditors force you to fix what was missed.


WHAT WILL YOU GAIN
  • Clarity on IEC 62304 requirements and how they impact FDA submissions
  • A structured list of deliverables and documentation needed for compliance
  • Risk-reduction strategies to prevent post-submittal audit findings


WHY TAKE THIS COURSE
  • Most 510(k) rejections trace back to weak or incomplete software files
  • IEC 62304 is now a baseline expectation—not an optional extra
  • Noncompliance can delay launches, trigger recalls, or block product sales


KEY AREAS COVERED
  • IEC 62304 vs. other quality standards like ISO 13485
  • Required documentation and software lifecycle deliverables
  • Work product development aligned to the standard
  • How IEC 62304 ties into your broader company QMS
  • Common causes of 510(k) denial for software-enabled devices
  • Legal and audit risks when IEC 62304 is not followed

Quality training, expert insights, and answers that matter. Know your Expert

NANCY KNETTELL

Nancy Knettell has spent 30+ years building and validating medical device software that saves lives—and avoids costly submission failures. She’s led teams at top firms like Smith & Nephew and Philips, and helped dozens of startups meet the bar for FDA acceptance. Her mission is deeply personal—and her standards are the gold standard.

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