What You'll Get From Customized Training Sessions

Understand how to apply ISO 10993 standards directly to your specific product and submission—no generic frameworks, just real-world strategies that address today's regulatory landscape.

Learn how to identify and close gaps in your biocompatibility evaluation, chemical characterization, or submission strategy before they become costly delays or rejections.

Walk away with a clear action plan for your next steps—whether that's structuring your data package, preparing for regulatory questions, or building expertise across your team.

Get insider knowledge from consultants actively involved in ISO TC194 committee work—stay ahead of emerging standards and regulatory expectations before they become industry-wide requirements.

Meet Your Trainer

Sandi Schaible

Founder and President, Bonded in Science, LLC

With 20+ years of experience in ISO 10993 evaluations and regulatory submissions, Sandi has guided hundreds of medical device teams through complex biocompatibility challenges. She's an active member of the ISO TC194 committee and specializes in helping teams optimize their submission strategies.

When Generic Courses Aren't Enough—Your Project Needs Real Expertise

You've completed the coursework. You understand the standards. But when you're staring down a complex biocompatibility evaluation, chemical characterization data gaps, or a regulatory submission timeline that won't budge, generic training doesn't cut it. That's where personalized coaching comes in. This isn't about learning theory—it's about solving your actual problems. Whether you're navigating ISO 10993-1, ISO 10993-18, or building internal expertise across your team, our coaching sessions are scoped directly around your submission, your product, and your regulatory challenges. You get direct access to consultants with 35+ years of industry experience and active involvement on the ISO TC194 committees shaping these very standards. We work with you on your timeline, your questions, and your unique needs—whether that's a focused one-on-one session, an extended workshop for your team, or onsite training customized to your internal processes and product portfolio.