A Complete Evaluation Framework

11 chapters covering every stage of choosing a lab — from spotting real E&L competency to structuring technical visits and audits, so you're never guessing whether a lab is actually qualified for your device.

A Toolkit You'll Actually Use

Ready-to-use scorecards and templates — including a master lab selection checklist, proposal evaluation scorecard, and information disclosure package — built for your next real project, not just theory.

Be a Good Client

Learn what to share, when, and how to protect your IP — because your lab's success (and your data quality) depends on what you bring to the partnership, not just who you hire.

About the course

Finding an E&L testing lab feels bigger than it should — there's no standard process, no one to ask, and a lot riding on getting it right. One bad choice can mean a repeat study, a reviewer who stops trusting your data, or a launch date that quietly slips by months. You already know the test; nobody ever taught you how to evaluate the lab doing it. This course closes that gap. You'll learn to spot real E&L competency, verify accreditation that actually matters, align with your lab on unknowns before testing starts, and read a proposal or report like someone who's seen what goes wrong — plus walk away with a master selection checklist, proposal scorecard, and disclosure template ready for your next project. Built from years on both sides of this relationship — inside E&L labs, and across the table from manufacturers living with the consequences of a rushed decision — this is the course I wish every one of them had. Enroll in Choosing a Chemistry (E&L) Testing Lab today, and make sure your next lab relationship is the one that goes right.

Sandi Schaible

I didn't build this course from a textbook — I built it from years spent on both sides of the table, inside E&L testing labs and across from device manufacturers trying to make sense of what those labs were telling them. I've seen extraction studies designed around a template instead of a device, reports that couldn't hold up to a reviewer's questions, and manufacturers who called me only after the damage was done — a repeat study, a reviewer who stopped trusting their data, a launch date that quietly slipped by months. None of that had to happen. Every one of those stories traces back to a handful of decisions made early, often without anyone realizing how much weight they carried. As an active participant in ISO TC194's working groups on chemical characterization and biocompatibility, I've spent years in the standards conversations that define what "good" looks like — but the real education came from the trenches. I built this one-of-a-kind course so the mistakes I've watched happen, over and over, to smart and careful people, won't happen to you.

Curriculum

11 Chapters · 65 Lessons

    1. (Included in full purchase)

      How to Use the Course Player

    2. Introduction to Selecting an E&L Lab Free preview
    3. (Included in full purchase)

      Where E&L Fits in Device Development

    4. (Included in full purchase)

      Your Lab is a Scientific Partner, Not a Vendor

    5. (Included in full purchase)

      What's at Stake When You Choose Poorly

    6. (Included in full purchase)

      What "Good" Actually Looks Like

    7. (Included in full purchase)

      Course Roadmap and What's Next

    8. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      Common Misconceptions in Lab Selection

    2. (Included in full purchase)

      The Difference Between a Chemistry Lab and an E&L Lab

    3. (Included in full purchase)

      What to Look For

    4. (Included in full purchase)

      What Real E&L Competency Looks Like

    5. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      What Does Competency Really Mean

    2. (Included in full purchase)

      Evaluating Competency

    3. (Included in full purchase)

      The Importance of Standards Fluency

    4. (Included in full purchase)

      Support After the Report

    5. (Included in full purchase)

      What Real Lab Competency Looks like

    6. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      What is ISO/IEC 17025 Accreditation

    2. (Included in full purchase)

      Is Accreditation Required For E&L

    3. (Included in full purchase)

      Accreditaton Claims vs Verified Scope

    4. (Included in full purchase)

      Quality Systems Beyond ISO 17025

    5. (Included in full purchase)

      What to Ask about Quality Systems

    6. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      Two Tools, Two Different Purposes

    2. (Included in full purchase)

      Determining Which One You Need

    3. (Included in full purchase)

      Structuring Visits and Audits

    4. (Included in full purchase)

      Visit and Audit Planning Checklists

    5. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      The Why and What of Complete Identification

    2. (Included in full purchase)

      What Alignment Looks Like

    3. (Included in full purchase)

      Where Misalignment Causes Problems

    4. (Included in full purchase)

      Questions to Establish Alignment Before Testing

    5. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      The Importance the Lab Proposal

    2. (Included in full purchase)

      What Strong Proposals Look Like

    3. (Included in full purchase)

      Comparing Proposals Apples to Apples

    4. (Included in full purchase)

      Questions to Ask Before You Sign

    5. (Included in full purchase)

      Proposal Evaluation Checklist

    6. (Included in full purchase)

      Quiz: Knowledge Check

    7. (Included in full purchase)

      Download: Lab Proposal Evaluation Scorecard

    1. (Included in full purchase)

      The Importance of a Sample Report

    2. (Included in full purchase)

      Red Flags in a Sample Report

    3. (Included in full purchase)

      ISO 10993-18 and FDA Reporting Requirements

    4. (Included in full purchase)

      Sample Report Review Checklist

    5. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      Technical Support Doesn't End with the Final Report

    2. (Included in full purchase)

      What Good Post-Project Support Looks Like

    3. (Included in full purchase)

      Get Expectations in Writing

    4. (Included in full purchase)

      Post Project Support Review Checklist

    5. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      Success Depends on You

    2. (Included in full purchase)

      When and What to Share

    3. (Included in full purchase)

      About IP and How to Share

    4. (Included in full purchase)

      What to Ask in Return

    5. (Included in full purchase)

      Good Client Review List

    6. (Included in full purchase)

      Quiz: Knowledge Check

    1. (Included in full purchase)

      Bringing it All Together

    2. (Included in full purchase)

      Download: Lab Selection Checklist and Scorecard

    3. (Included in full purchase)

      How to Use the Checklist & Score Card

    4. (Included in full purchase)

      Course Review and Final Thoughts

    5. (Included in full purchase)

      Final Exam: 15 Question Course Final

    6. (Included in full purchase)

      Download: Course Checklists and Guides

    7. (Included in full purchase)

      Course Feedback

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Enroll now and learn how to choose an E&L testing lab with confidence — before your next project is on the line.

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