Russell Sloboda has 40 years’ analytical chemistry experience (focusing on trace organics and inorganics analysis and mass spectral data interpretation) and 27 years’ toxicological risk assessment (TRA) experience.
With a focus on medical devices and drug product container closure systems, Mr. Sloboda has authored more than 226 TRA reports, and peer reviewed 120 reports. He has proactively contributed to several AAMI ISO working group committees and recently contributed key risk assessment methodology improvements that were adopted into the final draft international standard, (FDIS) ISO 10993-17.
Mr. Sloboda has a successful track record of negotiating with regulators to obtain 510(k) clearances from US FDA, CE mark approvals under EU MDR, and medical device approvals from Japan and China.
As a principal toxicologist at Nelson Labs, he peer reviews TRAs, provides support to analytical study design and interpretation of extractable/leachable (E/L) studies of medical devices, and assists clients in responding to FDA and EU regulatory concerns on medical device submissions.
In a prior position at DePuy Synthes, a division of Johnson and Johnson, he developed an efficient TRA report template used across the company’s MDR program and for new product development regulatory submissions. Over a 4-year period, he contributed toxicity profiles for 85 to 90% of chemicals assessed by a staff of ten toxicologists. In addition, he prepared toxicological risk evaluation reports for product nonconformance investigations, raw material and supplier process changes, and CAPA remediation.
At Toxikon Corporation, he authored TRAs, prepared proposals for E/L testing, risk assessment, and biocompatibility consulting, and represented Toxikon in FDA calls and deficiency responses. He is a graduate of University of Michigan’s Honors Program, with a dual major in chemistry and mathematics.
- Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17
- Wednesday, September 20 • 1:30 PM - 2:15 PM Eastern Time (US & Canada)