top of page

THE ACADEMY
- COURSE CATALOG

Training built by someone who was in the room   where the standards were written.

Not a summary of a PDF. Not a generic compliance overview. Every course comes from an active ISO TC194 committee member with 35+ years of hands-on industry experience — so what you learn is what you actually need translated in easy to understand language.

WHY IT'S DIFFERNT

This isn't another high-level overview course

Written from inside the standard

​

Sandi is an active member of ISO TC194 — the committee that develops and finalizes ISO 10993. You're learning from someone who helped shape the requirements, not someone interpreting them secondhand.

Built on decades of real practice

​

35+ years running chemical characterization, E&L, and biocompatibility programs — including executive leadership at a leading E&L Laboratory she built from scratch. Every course reflects what actually happens in a lab and a submission.

Practical, not theoretical

​

No filler, no padding to stretch a course longer. Each lesson exists because it solves a problem Sandi has personally been asked to solve.

Start where you are

​

Most topics run three levels deep — Basics, Intermediate, and Advanced — so a a new hire getting oriented and a seasoned expert land exactly where they need to. No sitting through fundamentals you've outgrown, and no getting lost in depth you're not ready for yet

Course Topics

Science based tracks. Basics through Advanced.

Every level of every topic is broken into small, focused lessons — about 20–30 minutes each, 6–8 lessons per course — so you can learn in the time you actually have. These self-paced courses let you move on your own schedule, reinforcing your learning along the way with short quizzes and helpful downloadable content. Each course ends with a certificate and a Q&A Session.

​

  • E&L for Medical Device

  • E&L for Pharma / BioPharma

  • Single-Use Systems (USP<665>)

  • Understanding & Using ISO 10993-1

  • Understanding & Using ISO 10993-18

  • Evaluating Chemistry (E&L) Testing Partners

  • Evaluating Biocompatibility Testing Partners

bottom of page