RA Support for Billion+ Medical Device Companies
FANG CONSULTING
Booth: 537
Fang Consulting recognizes your unique needs as a Billion+ medical device company and offers specific services that will contribute to the overall quality of your business and product. We bring value and take a proactive approach, from staff augmentation services to medical device strategy consulting, to support your day-to-day business.
-RA staff augmentation services
-RA project management
-FDA and other regulatory authority meetings
-FDA pre-submission meeting guidance
-Technical file development
-Short-term or ongoing project support
-EU MDR strategic gap analysis, remediation, and submission
-EU IVDR strategic gap analysis, remediation, and submission
-FDA strategy and submission support (Pre-submission, PMA, 510k, EUA, etc.)
-ROW/International submission support
-Product change reviews (ECO/CO) and RA assessments, including process, design and labeling changes