Total Hours Logged
Years of Experience
• Proposal Responses including US government agencies
• B2B White Papers and Case Studies
• Quality Management Systems
• Risk Assessment, Mitigation Plans, and Risk Management
• New Product Introductions
• Review clinical data (text journaled articles) and develop a data extraction table with specific inclusion/exclusion criteria for the company’s urology devices.
• Create a Clinical Data Report and Clinical Evaluation Report based on review of previous documentation and the articles reviewed. Develop a strategy for compliance to the EU MDR.
• Work projects on an
Due to a multi-decade interest in the financial markets and some negative experiences with paid financial planners, took on the responsibility of undertaking what turned out to be a huge challenge. Learned how options investing and the benefits it can bring in this low-interest rate environment. Important aspects include:
• Statistical analysis - critical to successful investing
• Risk management for capital preservation
• Develop and write Global Quality Processes (GQPs) and Templates as part of the company's overall quality strategy.
• Led a CER remediation project for a Class III device to comply with NB deficiencies to comply EU standards.
• Device Gap Analysis based previous Clinical Evaluation Reports (CERs).
• Develop a Clinical Evaluation Plan (CEP) template.