Recent experiences planning and remediating chemical characterization studies

Extractables analysis of medical devices is often performed to meet the requirements of chemical characterisation (ISO 10993-18) and leveraged to evaluate certain biocompatibility endpoints. Although extractables studies are seen as desirable alternatives to biological testing, they can have long lead times to completion, be costly to perform and be subject to careful regulatory scrutiny. Regulatory agency requests for study remediation – particularly requests for repeated testing – can have significant effects on project timelines and budgets. Therefore, it’s critically important to plan extractables studies using current best practices and customised approaches suited to the device’s composition and intended use. This Deep Dive session will draw upon MCRA’s recent experience as biocompatibility regulatory advisors, in which we have facilitated successful planning of extractables studies and remediation of agency deficiencies. We will discuss strategies for use of best practices, pilot studies, and pre-submissions to improve the likelihood of successful regulatory outcomes. 

External speaker: Dr Eric M. Sussman is an Associate Director of Biocompatibility at MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating US and international regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and cybersecurity. With 15+ years of experience in biomaterials science, biocompatibility, and regulatory affairs, Dr Sussman provides biocompatibility consulting services to medical device manufacturers for US and international regulatory submissions. 

Date and time: Tuesday, 25 October 2022, 5.00 pm (CEST) / 11.00 am (EDT)

Your speakers: Tyler Hollingshaus, Global Sales Marketing Manager

 Eric Sussman, MCRA

Register for free »