Kiran Dhakal, Phd, Mph, Nrcc, Dabt Email & Phone Number

Chapel Hill, Nc, Us

MEDICAL DEVICES - BIOCOMPATIBILITY AND TOXICOLOGICAL RISK ASSESSMENT-------------------------------------------------------------------------------------------• Medical device biocompatibility test plan per ISO 10993-1:2018 guidance and US FDA Guidance• E&L plan – solvent selection, extraction condition, and AET calculation per ISO 10993-18:2020• Toxicological risk assessment of E&L of medical devices per ISO 10993-17:2023• Biological Safety Evaluation Report• EU MDR Restricted Substances Assessment• Design and manufacturing change assessment• Gap assessment• Systematic literature review per ISO 10993-1 Appendix CIN VITRO DIAGNOSTICS----------------------------• Biocompatibility and safety assessment of the device per FDA and ISO 10993-1 guidance• Assay validation plan for determination of specificity, accuracy, precision, LOD/LOQ• Clinical evaluation report (CER)• Preparation of 510(k) submission package for FDA clearances for at-home testing kits CLINICAL LABS------------------• CMS 116 application for CMS/CLIA laboratory registration• High complexity laboratory directorship for Clinical Chemistry and molecular diagnostics• Vendor and reagent selection• Quality assurance – inspection proof templates for SOPs and forms for IQCP assessment• Laboratory inspection and audits per CAP/COLA/CLIA/NLCP/CAP-FDT requirements• Individualized quality control plans (IQCP)• Assay validation and performance verification• Training and staffing supportCOMPUTATIONAL TOXICOLOGY-------------------------------------• Statistical analysis and interpretation of data• Data visualization using Python and R• Evaluation of bioactivity of the chemical through computational model• Exposure assessment using PBPK modeling

Rush, Ny, Us

• Medical device biocompatibility test plan per ISO 10993-1:2018 guidance and US FDA Guidance (Cytoxicity, irritation, sensitization, hemocompatibility, genotoxicity, and implantation) of ocular devices• Extractable and leachable testing plan – solvent selection, extraction condition, and AET calculation per ISO 10993-18:2020 guidance• Toxicological risk assessment of E&L of medical devices per ISO 10993-17:2002• Biological Safety Evaluation Report for both external communicating and implant devices• EU MDR Restricted Substances evaluation• Design and manufacturing change assessment memo• Biocompatibility study gap assessment• Regulatory support for FDA and EU MDR health authorities• Literature review

Burlington, North Carolina, Us

• Drug/metabolite study and identification using LC/MS• Clinical and forensic toxicology data analysis and presentation • Preparation of lab SOPs• Validation of laboratory assays• Publications and communication in laboratory medicine and toxicology

Brooklyn, New York, Us

• Assay development and validation using LC/MS. • Drug metabolite identification. • Laboratory management and accreditation activities • Preparation for laboratory inspection from state and federal authorities

Bethlehem, Pennsylvania, Us

• Validation of pharmacogenetics/clinical chemistry/toxicology assay• Quality assurance and laboratory performance improvement • Review of Pharmacogenetics Taqman PCR assays data • Supervising and training of laboratory technologists

Davis, California, Us

• Investigated the effect of PCBs in neurodevelopment using primary culture neurons using transfection, PCR, and other techniques in molecular biology • Investigated effect of DFP, an organophosphate chemical, in persistent neurotoxicity using immunohistochemistry, MRI, and Proteomics techniques • Contributed in three manuscripts, one as a first author

Iowa City, Iowa, Us

• Studied environmental issues and adverse health effects of Polychlorinated Biphenyl (PCBs) and other Persistent Organic Pollutants (POPs) in the environment• Teaching assistant for a graduate level course in "Environmental Health"• Carried out inhalation exposure of Polychlorinated Biphenyls (PCBs) in rodents• Developed, validated and optimized a method for the extraction of phenolic and conjugated metabolites from urine, serum, bile and tissues using various solid phase extraction (SPE) and liquid-liquid extraction techniques• Quantified PCBs and its metabolites using HPLC, LC/MS and GC/MS• Carried out PK/PD analysis of airborne PCB3• Studied genotoxicity of PCBs using comet assay and direct urinary analysis of oxidative DNA metabolites (8-Oxo-dG)

Manhattan, Ks, Us

• Graduate research assistant in the Toxicology lab (Department of Pathobiology)• Studied epidemiology of infectious diseases• Evaluated Cytotoxicity and Immunotoxicity of Metal Oxide Nanoparticles using human bronchial epithelial cell line (Masters thesis)

Doctor Of Philosophy (Ph.D.), Human Toxicology

Master Of Public Health (Mph), Environmental Health/Infectious Diseases

Doctor Of Veterinary Medicine, Dvm