Medical Device Biocompatibility & Toxicology Risk Assessment ConferenceJune 23-24, 2020 | Alexandria, VA
Examination of Increasingly Complex Regulatory Requirements Governing Risk-Based Biocompatibility & Toxicological Assessments, Analysis of Industry Compliance with EU MDR, Considerations in Streamlined Test Planning and Design, & Risk Management via Material Selection & Process Controls
Recent updates to the ISO 10993 standard series governing biocompatibility have within the course of a decade revolutionized the framework according to which a thorough biological evaluation of medical devices must be undertaken, and thus have redefined the scope and import of biocompatibility & toxicological expertise for the compliant design and commercialization of medical devices in the both the United States and Europe. The rapid expansion of these roles alongside extensive FDA and notified body guidance implies a new depth of nuance in device evaluation for which industry executives are keen to account with the requisite organizational skill base. As a result, an urgent need exists for industry education and collaboration in clarifying practical paths forward toward safe and effective device design, commercialization, and requalification.
Q1 Productions’ Medical Device Biocompatibility & Toxicology Risk Assessment Conference will provide medical device biocompatibility, toxicology, regulatory, and quality executives technical guidance on the efficient management of biological and toxicological risk according to FDA and notified body interpretations of ISO 10993. Attendees will leave equipped with current best practices for building effective test plans, executing chemical characterizations, avoiding unnecessary testing, proper responses to supplier/manufacturing alterations, and rectifying failed submissions.