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In the world of medical devices, combination products and pharmaceutical products, extractables and leachable (E&L) testing is often viewed as a regulatory checkbox. But for those of us who’ve spent decades in the trenches of chemical characterization, we know that “good” E&L isn’t just about meeting minimum requirements—it’s about solid data to support a risk assessment to protect patients, enable innovation, and build trust. So, what does good E&L look like? Good E&L testin

In today’s medical device landscape, biocompatibility is no longer a checkbox-it’s a strategic pillar of product safety and regulatory success. With the upcoming release of the latest revision to ISO 10993-1 (currently a Final Draft International Standard (FDIS)), the integration of chemical characterization (ISO 10993-18) and toxicological risk assessment (ISO 10993-17) is more critical than ever. These standards now align closely with I SO 14971:2019 Medical devices-Applica