Medical, Quality, and Compliance consultation services for class II/III medical device companies range from Post Market Surveillance and Post Market Process Remediation, MDR/MDV evaluation/reporting, and Risk Mgmt. Activities (EN ISO 14971:2012), which include patient safety references (identification of hazard/hazardous situation in FMEAs, approximation of prob. of hazardous situation (P1) and prob. of occurrence of harm (P2), Health Hazard Evaluations (HHE), Performance Evaluation Reports (PER) and Clinical Evaluation Reports (CER); Gap Assessments and Remediation of Standard Operating Procedures (SOP) involving PER/CER for compliance to new EU regulations, etc. Assessing for and preparing rationale for regulatory authorities for the scientific validity of instruments based on device performance for in vitro diagnostic devices (IVDD), analytically and clinically, with adequate literature review for justification.- CER assessment and standard operating procedures remediation. - Clinical assessments for risk remediation, adverse events, and determination of Field Corrective Action.- Literature reviews supporting claims in risk documentation and promotional material. - Provide analysis and input to clinical and scientific aspects of regulatory filings, including technical summaries, labeling statements, IFU, Annual Progress Reports, CER, PER, and risk management reviews.- Work with marketing teams to develop an education curriculum for field associates, new clients, physicians, and internal staff related to the clinical utility of the product and awareness of the disease pathology for which the device will assist patient care and patient safety.

- Serve as an advisor for a medical software company reporting directly to the CEO/Founder of a software startup that has successfully been through two seed rounds of funding at the University of California - Irvine. - Serve as ambassador for SOS, which has successfully launched in several hospital systems globally and promoted by the American College of Surgeons (ACS). - Pressure-test each system version from the perspective of an MD and provide constructive criticism and feedback to ensure thorough risk assessment completed and software design with appropriate mitigations. - Participate in brainstorming sessions and workshops with focused groups and research of the physician market and competitor analysis.

• Review all escalated patient safety issues from post-market data to ensure patient safety.• Review Clinical Trial data (IDE) for complaint initiation and adverse event evaluations. • Participate in quarterly quality management reviews and risk management review meetings. • Provide clinical risk assessment/impact relating to fielded products and recommendations for action to senior management as appropriate. • Work with key opinion leaders and accounts to obtain the Voice of the Customer. • Provide clinical/scientific input in the development and execution of clinical trials (Phase I, II, III, & Post Market Surveillance). • Work with New Product Development (NPD) to improve products and minimize patient impact. • Participate in responses to regulatory authorities (i.e., FDA, MHRA, BfArM, Notified Body).• Work with Physicians conducting clinical trials to understand the root cause of identified errors. • Lead changes to the Risk Management process, Health Hazard Evaluations (HHEs), and Risk-Benefit Analysis to ensure compliance with EN ISO 14971:2012. • Lead completion of HHEs and Risk-Benefit Analysis (RBA) for all identified patient safety issues to determine whether a recall or stopship would be required. • Review and provide complication rates derived from post-market data.• Create a medical library of terms and definitions for consistent coding and trending. • Review medical and scientific literature for use in marketing and promotional material. • Lead integration of the quality system for clinical risk management processes of the newly acquired company. • Work directly with key accounts/vascular surgeons to identify whether patient complications were procedure/product/patient-related. • Develop and maintain professional relationships with academic and community-based sites.• Provide new hire training on basic science, patient safety, and clinical utility of the product.

• Collaborate with New Product Development (NPD), Marketing, and Post-Market Quality (PMQ) by acting as a team member to provide clinical input into product design improvements, product risk management, updates to labeling, and promotional material.• Provide clinical input on evaluations to determine MDR/MDV/MPR reporting for customer complaints. • Conducting Health Hazard Evaluations (HHEs) for all identified patient safety issues to determine whether or not a recall would be required. • Develop and maintain professional relationships with academic and community-based sites.• Do research to compile data to support the determination of severity and probability of harm for Post-Launch Risk Assessments (PLRAs) and HHEs.• Provide clinical recommendations to improve products to increase the detectability of product failure at the point of use to minimize the patient impact. • Work with the Manager of Quality Systems to provide medical perspective/background, if needed, to respond to inquiries by international authorities.• Work with the Manager of Quality Systems and the Manager of Complaints to provide medical perspectives or differences in the standard of care that can affect complaints received from different geographies.• Ensure that product safety and performance analyses are data-driven and scientifically sound.• Establish and maintain a clinical library of medical literature and references that can be used for internal justification purposes. • Participate in maintaining Quality Risk Management activities throughout the product life cycle. Ensure ongoing compliance/alignment with FDA, ISO 14971, and other applicable regulatory requirements and continuous program improvement consistent with industry standards and practices. • Participate in Quality Management Reviews and take the lead in Risk Management Review Meetings to drive product and process improvement.

• Taught my 50th medical student client before the end of 2018. • Fast-forward to 2023, with a 99% pass rate for medical students who took their US Medical Licensing Exams (USMLE) with me as their primary guide. • I created a unique board-prep curriculum for US MD candidates and International Medical Graduates (IMGs). • Build curriculum and medical mnemonics, which facilitate retention of medical information for board certification.• Assisted students from internal medicine programs, general surgery, physician assistant, physical therapy, and occupational therapy with medical educational support, coaching, and mentorship.I also worked as a freelancer for:• Kaplan Curriculum, NYC• Becker Medical, Dallas, TX (fka Falcon Physician Reviews)• Med School Tutors (Blueprint)Specialized in step 2 clinical knowledge preparation for the United States Medical Licensing Examination (USMLE®), specifically for internal medicine in general and subspecialties (i.e., toxicology, OB/GYN, and pediatric emergency, advanced cardiac life support (ACLS), and ICU patient management), as well as trauma surgery & emergency medicine. • Develop, design, and implement customized study plans and curricula to optimize their understanding and retention of difficult-to-learn concepts and hold them accountable.• Assess student performance by identifying strengths and weaknesses by administering and reviewing NBME exams and my gap assessments, which include multiple-choice clinical-vignette questions and straight-forward fill-in-the-blank questions to assess baseline knowledge and trending assessments for ongoing progress.• Creating questions and clinical case studies to challenge and gauge knowledge retention. • Creation of various forms of quality medical mnemonic devices that STICK!• Customized coaching and guidance on test-taking skills to optimize scores for the USMLE exam.• Teach students how to interpret and deconstruct exam questions to provide accurately required answers.

Worked for Falcon Physician Reviews before Becker USMLE® acquired them USMLE® Student AdvisorTeacher's Assistant (Dr. Edward Goljan's class)Medical Input (cross-functionally)Marketing AssistantMusical mnemonic and medical music song creation working under the Director of Medical Education

Created an album of medical songs with John Barone, M.D., professor of pathology at Cedar Sinai Medical Center, LA and Kaplan Medical via his company Thunderpath Media, Inc. (https://www.baronerock.com)

-Inpatient service and outpatient clinic-Patient triage in the Emergency Department-Member of the Cardiac Arrest Team and Rapid Respond Team for emergency medical intervention.-ECG interpretation for diagnosis and treatment of cardiac and pulmonary conditions.-Conducting medical evaluation and assessment of hospitalized patients for qualification for treatment in the Medical ICU and Coronary Care Unit -I assisted electrophysiologists in conducting EP studies on patients with various cardiac rhythm abnormalities and electrical dysfunction. I helped the cardiac catheterization team and interventional cardiologists when performing percutaneous coronary intervention (PCI).-Conducting detailed/focused history and physical examination.-Creation of detailed diagnosis and treatment plan using evidence-based medicine. -Procedural Certifications: Endotracheal intubation/extubation, Central venous line placement (internal jugular/subclavian/femoral veins), Swan-Ganz catheter and Shiley catheter placement, Arterial Blood Gas obtained from the radial artery, paracentesis for diagnosis and treatment, Foley catheter/urethral placement, NasoGastric (NG)Tube Placement, detailed analysis of blood and urine test results for diagnosis and monitoring of disease progression, chest tube placement, deconstruction of urine toxicology for drugs of abuse, advanced cardiac life support, resuscitation of unstable patients, Indications ad maintenance of mechanically ventilated patients, intravenous IV and Heplock placement, pericardiocentesis, thoracocentesis, arthrocentesis, lumbar puncture for cerebrospinal fluid analysis.-Root cause evaluation for inadvertent patient mortality and permanent impairment of a bodily function (morbidity). Presentation of root cause analysis to the medical board to determine appropriate corrective and preventive action. -Management and modification of patient risk associated with the treatment of diseases in an outpatient clinical setting.

* Medical input of basic sciences and clinical knowledge. * Constructed Kaplan Q-bank questions backed up by literature review for specific topics* Revamped the entire internal medicine section, including subspecialties (such as cardiology, gastroenterology, endocrinology) * Documented justification and rationale behind each correct and incorrect answer and a “bottom-line” simplified summary.

I was a medical student advisor on career direction, examination, and matching them up with a Kaplan solution. Student progress was tracked with exam results and course-correcting plans if necessary. I also gave medical input on incorrect answers to Kaplan Q-bank questions if an additional explanation was warranted.

EMT-B NYS Badge #: 247579

EMT-B NYS Badge#: 247579