Consulting ServicesMedical Devices

RA Support for Billion+ Medical Device Companies


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

Other product: CO Review

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