Select Projects

Biological Safety Evaluations:  Evaluated medical devices for biological safety to ensure compliance with US FDA and EU MDR regulations.  Developed in vivo and in vitro testing schemes to address biological endpoints and authored justifications to waive testing when appropriate and feasible.  Authored biological safety evaluation plans and reports inclusive of in vivo and in vitro biocompatibility results, chemical characterization evaluations, toxicologist risk assessments, material and manufacturing analyses, and justifications for non-testing.

Medical Device Regulation Gap Assessments:  Performed gap assessments to EU MDR and US FDA regulations and developed remediation strategies.

Evaluation of CMR/ED Substances in Medical Devices:  Supported EU MDR regulation compliance under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation for carcinogenic, mutagenic, or toxic to reproduction (CMR) substances and endocrine-disrupting (ED) substances, including benefit-risk justifications for CMR/ED substances in alignment with Regulation (EC) No 2017/745, Annex I, GSPR 10.4.1.

Consumer Product Skin Sensitization Risk Assessment:  Performed hazard assessments and quantitative risk assessments for skin sensitization and irritation after potential exposure to constituents of various consumer products designed to be in contact with the skin.  Developed exposure levels for potential chemicals of concern intended to protect consumers from adverse skin reactions from contact with the products.

Compliance to California’s Proposition 65:  Developed Safe Harbor Levels and performed exposure assessments to evaluate compliance to California’s Proposition 65 for various consumer products.

Pesticide and Fungicide Hazard Assessment:  Performed hazard assessments for pesticides and fungicides designated for use in public areas in accordance with county government guidelines.

Product Safety Risk Assessment:  Determined allowable concentrations of various metals and chemicals in cloth uniforms and metallic jewelry and accessories to prevent adverse reactions from dermal contact and accidental ingestion.

Selected Publications

Ticknor, RC. 2022. “Skin sensitization potential of medical devices.” Gradient Trends – Risk Science & Application 85:3,9, Fall.

Goodman, JE; Ticknor, RC; Zhou, J. 2022. “Response: Alternative approaches for systematic review.” Glob. Epidemiol. doi: 10.1016/j.gloepi.2022.100091.

Goodman, JE; Ticknor, RC; Zhou, J. 2022. “Systematic review of perchloroethylene and non-Hodgkin’s lymphoma.” Glob. Epidemiol. 4:100077. doi: 10.1016/j.gloepi.2022.100077.