Future Path for E&L per ISO 10993‑18: A Look at Emerging Technical Specifications

ISO 10993‑18 is entering a new phase as several technical specification (TS) documents are developed to address long‑standing gaps and confusion in chemical characterization. These TS efforts aim to bring greater clarity to extraction design, identification confidence, quantitation strategies, and quality for better alignment with ISO 10993‑17 for toxicological risk assessment.

This presentation summarizes the TS documents currently in development, outlines their intended scope, and highlights how they may reshape expectations for E/L study design and reporting. Attendees will gain a concise view of where ISO 10993‑18 is heading and practical insight into how these evolving documents may influence regulatory submissions and laboratory practices in the future.

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.

Rising to the Standard: How Advanced Analytics and Machine Learning Meet the New E&L Standards

The emerging technical specifications under ISO 10993-18 raise expectations for identification confidence, quantitation accuracy, and overall data quality, but meeting those expectations demands more than procedural change. It requires advancing the analytical science itself.

This presentation focuses on the technical strategies that improve the reliability of extractables and leachables data. It examines the sources of uncertainty that undermine identification and quantitation, and the methods that address them: enhanced analytical workflows, effective approaches to compound identification, and rigorous quality controls that produce defensible, submission-ready results.

Particular attention is given to the role of machine learning. Data-driven models are beginning to transform how compounds are identified and how analytical responses are predicted, closing gaps that traditional methods leave open and elevating both the confidence and consistency of E&L results. These tools do not replace sound analytical chemistry, they extend it, enabling laboratories to meet the higher standards the new specifications will demand.

Attendees will gain a practical, forward-looking view of how advanced strategies and emerging technologies can be applied today to strengthen data quality, support identification confidence, and prepare E&L programs for the requirements ahead. Ideal for those responsible for analytical chemistry, biocompatibility strategy, and regulatory submissions.

Presented by Kevin Rowland, M.S, Executive Vice President and General Manager at Jordi Labs

Kevin Rowland, M.S. earned his bachelor’s degree in Ceramic Engineering in 2001 and a master’s degree in Materials Science and Engineering in 2003, both from Alfred University. He went on to Brown University, where he earned a second master’s degree in Chemistry in 2008 under the mentorship of Dr. Brian Moulton, with research focused on molecular self-assembly. Kevin has spent over 17 years at Jordi Labs, growing through roles of increasing responsibility. From leading the GCMS and LCMS teams to serving as Laboratory Manager and Director of R&D, his career has been driven by a passion for scientific innovation. Along the way he’s built deep expertise in extractables and leachables testing, high-resolution mass spectrometry, and the identification of non-targeted, unknown compounds, all of which are central to advancing biocompatibility science for medical devices and pharmaceutical packaging. Now serving as Executive Vice President and General Manager, Kevin shapes the strategic direction of Jordi Labs with a focus on innovation in biocompatibility testing and chemical characterization, delivering high-quality science to clients across the medtech sector. He’s committed to scientific rigor, service excellence, and pushing the boundaries of what analytical chemistry can do.

Followed by a live question and answers session

Sponsored by Jordi Labs

Jordi Labs is a specialized analytical chemistry laboratory and division of RQM+, the full-service MedTech CRO delivering regulatory, clinical, and laboratory expertise across the product lifecycle. Founded in 1980 on the principles of integrity, excellence, and innovation, Jordi Labs has spent more than four decades helping manufacturers navigate complex analytical challenges with speed, precision, and scientific rigor. At the core of Jordi Labs’ expertise is extractables and leachables (E&L) testing and biocompatibility evaluation for medical devices. ISO/IEC 17025:2017 accredited and backed by state-of-the-art instrumentation and a team of expert analytical chemists, Jordi Labs delivers end-to-end biocompatibility services from study design through toxicological risk assessment, built to meet the demands of global regulatory submissions. Beyond E&L, Jordi Labs offers method development and validation, materials consulting, polymer failure investigation, and particulate and residue analysis, with a global client base across medical devices, pharmaceuticals, and consumer products. As part of RQM+, Jordi Labs operates within a full-service MedTech ecosystem spanning regulatory strategy, quality management, clinical trials, and reimbursement, giving clients a single integrated partner from concept through commercialization.