Fit for Purpose Chemical Characterization Studies for Medical Devices: A Practical Approach

Physical and chemical information underpins biocompatibility assessment under ISO 10993-1, yet rigor in chemical characterization (ISO 10993-18) is often assumed to scale only toward more testing and tighter analytical precision. This presentation challenges that assumption from three angles.

First, not every device needs a new extractables and leachables (E&L) study. A gap analysis of existing information, including material master files, compendial data, predicate device characterization, and prior toxicological risk assessments, can support a documented, auditable rationale in place of new testing when it establishes a conservative Analytical Evaluation Threshold and safety margin.

Second, where testing is warranted, chasing analytical-grade precision (e.g., 80–120% recovery) can create an illusion of rigor when greater uncertainty exists upstream in extraction methodology, manufacturing, raw material sourcing, and site transfers.

Third, robust chemistry data paired with a toxicological risk assessment per ISO 10993-17 can support waiving or reducing separate biological testing, lowering animal use with broad regulatory acceptance.

Together, these questions (whether to test, how precisely, and which biological endpoints the data can answer) define one principle: allocate scientific effort where it changes the risk conclusion, not where it satisfies historical defaults. The presentation offers a practical framework for justifying the scope, necessity, and value of chemical characterization, with patient safety as the ultimate measure of success.

Followed by a live question and answer session

Presented by Sandi Schaible, President and Founder of Bonded in Science, LLC

Sandi Schaible is the President and Founder of Bonded in Science, LLC a consulting firm dedicated to delivering scientific strategy and regulatory guidance for the MedTech and Pharma/BioPharma industries. She has more than 35 years of experience—including nearly three decades in contract research organizations and 20 years in executive laboratory leadership.  As an international expert and active member of ISO TC194/WG14 for nearly a decade, and recently elected to serve as an expert to ISO TC194/WG1, Sandi offers unparalleled expertise in analytical chemistry, biocompatibility, and regulatory strategy for extractables and leachables (E&L).

Sandi has led organizations through complex analytical transformations, building robust programs that combine scientific rigor, regulatory compliance, and a customer-centric approach. Her work spans both medical device and pharmaceutical sectors, helping clients meet global regulatory expectations for E&L testing.

Through Bonded in Science, Sandi provides advisory and leadership support to laboratories, positioning them as trusted partners in regulated industries. She also delivers training and analytical support to MedTech and Pharma clients while actively contributing thought leadership and collaborative initiatives that advance the science of extractables and leachables.