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A modern eQMS for product-led,
fast-moving medtech innovators.

  • Built to fit your process, not force it
  • Stay focused on product, not paperwork
  • Built for engineers and trusted by auditors

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An eQMS for product-led,
fast-moving medtech innovators.

  • Flexible to support how you work
  • Help engineers stay compliant as they build
  • Integrates with your existing tech stack

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An eQMS for established and
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  • Built for global scale
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designed for medtech clinical trials.

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  • A single platform for all your studies
  • Facilitating ISO 14155 and 21CFR Part 11 compliance

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QMSR is coming. Is your quality system ready?

This page is your one-stop resource for understanding what’s changing, what’s at stake, and how to stay compliant.

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Right data in, right decisions out: mastering chemical characterization for safe medical devices 

 
Chemical characterization (CC) data form the backbone of a medical device’s biocompatibility and toxicological safety assessment. Yet in practice, CC is one of the most misunderstood and error-prone parts of biological evaluation. Choices made early (such as extraction conditions, analytical techniques, reporting thresholds) often have unintended consequences downstream, limiting what toxicologists can conclude and triggering costly delays, repeat testing, or regulatory challenge. 
This panel brings together experienced toxicologists, chemists, and biocompatibility professionals to critically examine the weak spots in current CC practice. We will explore why “garbage in, garbage out” is more than a cliché, review where CC data often fail to answer safety questions, and debate how evolving standards (ISO 10993-18 and -17) are exposing gaps in long-standing approaches. Expect a candid, experience-driven conversation about what goes wrong, why it matters, and where industry struggles most. 
 

Key learnings:

  • Understand where CC most often fails (what are the major issues?) 
  • See how misaligned CC data limit toxicological risk assessment and lead to “garbage in, garbage out” safety evaluations 
  • Learn from real life examples
  • Regulatory challenges with data acceptance
Target audience 
  • Regulatory Affairs Professionals & Management
  • Product Development Engineers and Management
  • Others: Toxicologists, Chemists, Biocompatibility experts

Watch now!
Copy of DO NOT USE-Webinar Wide (2)
Who should attend?
  • Medical Device Executives
  • Product Development Engineers and Management
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
  • Clinical Affairs Professionals and Management
Register Now  

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