Dhanmati Rupnarine has 32+ years of professional experience in global Compliance, Quality, and Regulatory having served in regulated industries covering medical devices products, drug-device combination products, pharmaceuticals, in vitro diagnostic (IVD) products and software in markets worldwide. Her experience also includes program management, company acquisitions, integrations and divestitures.
Dhanmati has expertise in global regulations, industry standards and has led various consulting projects at medical device, and pharma companies. During her years within the industry, she worked on projects in the design, development and launch of new and modified products, outsourced medical devices and supplier management. She is a subject matter expert in the establishment, implementation, remediation, maintenance and evaluation of medical devices and pharmaceutical Quality Management System (QMS), global quality, compliance, regulatory, design controls, current Good Manufacturing Practices (cGMP), validations, software as a medical device, audits, due diligence, usability and human factors, risk management, gap assessment, complaints, vigilance, post-market surveillance,, regulatory submissions, training and remediation activities in support of addressing regulatory and/or enforcement actions.
Dhanmati is an NSF consultant working on Quality and regulatory consulting projects that focus on effectively supporting client engagement teams and consistently deliver high quality deliverables. She earned her Bachelor of Science in food science from the University of Manitoba; her Master of Science in quality management, with honors, from the University of Miami; and her doctorate in business administration in quality systems management from the National Graduate School of Quality Management in Boston, Massachusetts.
Areas of Expertise:
- Regulatory Inspections and Audits
- Quality Management Systems
- Global Medical Device Regulations
- Design Control and Risk Management
- Post-Market Surveillance
- Drug-Device Combination Products
- Premarket Clearance for U.S. FDA, EU MDR and EU IVDR