Registration is required for this free webinar
Hosted by the SOT Medical Device and Combination Product Specialty Section
This webinar presents a contemporary, science-based framework for evaluating particulate risk for medical device manufacturing. The first half introduces a risk-based approach to set particulate acceptance criteria using toxicological safety thresholds and clinically relevant endpoints, then translating allowable limits into practical manufacturing specifications for visual inspection and quality control. The second half presents case studies illustrating approaches to assess particulate hazards and risks in medical device using case studies, e.g., a vascular device assessment using ISO 14971-5 with semi-quantitative likelihood-severity scoring informed by preclinical/characterization data, and a breathing gas pathway example emphasizing material degradation and how end-of-life testing strengthens risk evaluations under increasing regulatory scrutiny.
Speakers
Shahid Parvez, PhD, DABT, Principal Toxicologist, Intuitive Surgical
Sharlee More, PhD, DABT, Director, Toxicology, MCRA