Using ISO 11607 to Develop Risk-Based Device Packaging

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So did Customed, Inc. — until it was hit with a record-breaking recall of 233 Class I products, representing several hundred thousand units.

All because of packaging flaws.

Was Customed an industry outlier? An isolated case?

Not really. From 2010 to 2012, flawed packaging was cited in nearly 400 other Class II and Class III recalls.

These citations demonstrate once again that building packaging quality systems and deploying packaging engineering are not simple tasks.

Are you on top of the best practices you need to design and create your packaging correctly — every time?

If you're concerned — and you should be — there's a new management report from FDAnews that can help you.

Using case studies and other frontline knowledge, Using ISO 11607 to Develop Risk-Based Device Packaging will show you how to leverage a risk-based packaging approach to prevent recalls and nasty audits … without busting a hole in your compliance budget.

With it, you'll get step-by-step guidance through the bewildering FDA packaging requirements, beginning with a discussion of how and why packaging is causing significant harm to devicemakers.

You'll also learn why your packaging might be at risk — and what you must do to reduce field complaints, recalls or FDA enforcement actions.

With the knowledge you'll gain from this report, you will quickly find out how to:

  • Navigate myriad packaging standards (that increase each year)
  • Identify the most important flaws or shortcomings in your medical device packaging program
  • Show an FDA inspector that you understand the agency’s packaging requirements
  • Understand what FDA audit spots investigators are focusing on during device inspections
  • Troubleshoot your vulnerable packaging areas and remediate your program based on defensible risk assessment
  • Learn from the mistakes of others to apply proven risk-based decision-making when developing a stronger device packaging program
  • And more

Most importantly: You'll find out the real specifics that FDA investigators consider when they’re debating if it’s time to recall your product.

That's why ordering this report is a no-brainer.

Let the experts at FDAnews help you better understand what's at stake for your company and why risk-based packaging can make all the difference.

Order Your Copy Today!

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Table of Contents

  • Introduction
  • Governing Standards for Device Packaging
  • The Role of Device Packaging
  • Risk-Based Decisionmaking for Device Packaging
  • And More …

View the entire TOC

Meet the Author

This report is based largely on an FDAnews webinar featuring Abhishek (Abhi) Gautam, manager of packaging engineering at ConMed Corp. Gautam is a packaging engineer with 12 years of experience in the medical device sector (orthopedics, cardiovascular and surgical).

He has written multiple articles and presented multiple times and enjoys contributing to the medical device packaging industry. He is also a co-inventor on several groundbreaking patents in field of packaging design and application.

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