Consulting ServicesMedical Devices

RA Support for Mid Size Medical Device Companies

FANG CONSULTING

Booth: 537

As a midsize company in the medical device industry, you often face the dilemma of being short-staffed during peak workloads, lacking the necessary expertise for a specific project, or not having necessary bandwidth to achieve your key business initiatives. Fang Consulting has diverse experience in the medical device industry to navigate those staffing challenges. Our team’s staff augmentation and consulting leadership provides peace of mind. We hit the ground running and immediately impact productivity. -RA staff augmentation and short term resources (e.g., employee medical or maternity leave) -RA project management -FDA and other regulatory authority meetings -FDA pre-submission meeting guidance -Technical file development -Short-term or ongoing project support -Person Responsible for Regulatory Compliance (EU MDR Article 15) -EU MDR strategic gap analysis, remediation, and submission -EU IVDR strategic gap analysis, remediation, and submission -FDA submission support (PMA, 510k, EUA) -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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