Demystify the science

Understand what extractables and leachables actually are, where they come from in your device, and why they matter for patient safety — explained in plain language without assuming a chemistry background.

Know your obligations

Learn exactly where E&L fits within ISO 10993 and the FDA's biocompatibility framework, so you can make informed decisions at every stage of product development.

Work smarter with your lab

Walk away knowing the right questions to ask, what to expect from a testing program, and how to interpret what your lab sends back — so you're never in the dark on a critical submission.

About the course

Stop Guessing About Extractables and Leachables — Understand Them Instead That moment in the meeting when extractables and leachables come up? You're about to own it. If you work in quality, regulatory, R&D, or biocompatibility, you've likely felt out of depth with E&L conversations. Here's why: E&L requires knowledge across chemistry, toxicology, and regulatory strategy — disciplines most professionals weren't trained in. This course bridges that gap with practical, real-world knowledge. You'll understand what extractables and leachables are, where E&L fits in ISO 10993, and how to guide your testing lab confidently. You'll master device classification, read lab reports with certainty, and know exactly what to ask before starting any study. The difference? I've managed major E&L testing labs and sit on the ISO working groups that write these standards. You're learning from someone who shapes the industry, not just explains it. Stop guessing. Start understanding. Enroll now.

Sandi Schaible

Sandi the Founder of Bonded in Science, LLC is a recognized expert in chemical characterization, biocompatibility, and extractables and leachables testing for the medical device and pharmaceutical industries. With hands-on experience building and managing a large-scale E&L testing laboratory, she brings rare operational depth to regulatory topics that are often taught only in the abstract. Sandi is an active membership on ISO TC194 WG1 and WG14 — the very committees that write the standards this course is built on — giving students direct access to insight that most training programs simply can't offer. Through Bonded in Science, she works with manufacturers and testing laboratories to navigate the intersection of science, compliance, and strategy.

Curriculum

8 Chapters · 48 Lessons

    1. (Included in full purchase)

      How to Use the Course Player

    2. Course Introduction Free preview
    3. (Included in full purchase)

      What are Extractables and Leachables

    4. (Included in full purchase)

      The patient safety connection

    5. (Included in full purchase)

      Real-world consequences: what happens when E&L goes wrong

    6. (Included in full purchase)

      Where E&L fits in the product lifecycle

    7. (Included in full purchase)

      Quiz: Knowledge Check

    8. (Included in full purchase)

      Download: E&L Glossary of Key Terms

    1. (Included in full purchase)

      Overview of the ISO 10993 series

    2. (Included in full purchase)

      Where E&L lives: ISO 10993-18 (Chemical Characterization) in context

    3. (Included in full purchase)

      How FDA biocompatibility guidance aligns (and where it diverges)

    4. (Included in full purchase)

      The Biological Evaluation Report (BER)

    5. (Included in full purchase)

      What's changed with ISO 10993-1:2025

    6. (Included in full purchase)

      Quiz: Knowledge Check

    7. (Included in full purchase)

      Download: ISO 10993 Series Quick Reference Map

    1. (Included in full purchase)

      Types of materials commonly used in medical devices

    2. (Included in full purchase)

      How manufacturing processes introduce chemical risk

    3. (Included in full purchase)

      Contact Type and Duration Drive Testing Requirements

    4. (Included in full purchase)

      Thinking like a regulator: patient exposure scenarios

    5. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      Extractables: Worst Case Scenario

    2. (Included in full purchase)

      Leachables: Clinical Use Exposure

    3. (Included in full purchase)

      The Analytical Methods

    4. (Included in full purchase)

      What "identified" vs. "unidentified" compounds Impact your Program

    5. (Included in full purchase)

      Checklist and Key Take Aways

    6. (Included in full purchase)

      Quiz: 5 Knowledge Check

    1. (Included in full purchase)

      The Analytical Evaluation Threshold

    2. (Included in full purchase)

      How it Fits into ISO 10993-17

    3. (Included in full purchase)

      Introduction to the Toxicological Risk Assessment

    4. (Included in full purchase)

      Checklist and Summary

    5. (Included in full purchase)

      Knowledge Check

    1. (Included in full purchase)

      E&L Timelines

    2. (Included in full purchase)

      Information for the Laboratory

    3. (Included in full purchase)

      Extraction Types

    4. (Included in full purchase)

      Study Basics-Extractions

    5. (Included in full purchase)

      Common Mistakes Manufacturers Make

    6. (Included in full purchase)

      Quiz: Program planning decision tree exercise

    1. (Included in full purchase)

      Evaluating and Selecting a Qualified Lab

    2. (Included in full purchase)

      Understanding Scope of Work

    3. (Included in full purchase)

      How to Read a Report

    4. (Included in full purchase)

      Communication Tips

    5. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      Building Your Own Internal E&L Knowledge

    2. (Included in full purchase)

      How to Talk About E&L with Leadership

    3. (Included in full purchase)

      Common FDA and Notified Bodies Questions

    4. (Included in full purchase)

      Course Summary and Key Takeaways

    5. (Included in full purchase)

      Final Assessment: 15-question comprehensive quiz

    6. (Included in full purchase)

      Course Feedback

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