Our Services

FDA Regulatory Device Consulting

FELLMAN DEVICE GROUP SERVICES

Fellman Device Group is ready to provide personalized support for your regulatory needs including regulatory strategies, submissions, risk assessments, test development, clinical studies, recalls and more.

Regulatory assessments and regulatory strategy development for all types of new products

SUBMISSION PREPARATION OR REVIEW – PMA, 510(k), IDE, DE NOVO, HDE, 513(g)

Q-Submission preparation or review – Pre-subs, Breakthrough devices, Study risk, Classification

Risk/hazard assessments, bench testing and preclinical testing support

Clinical study development support (pre-market & post-market)

Device labeling, Instructions for use, and Safety communications

Appeal and Panel meeting support

Compliance, Recalls and Root-cause analyses support

Medical device reporting support

FDA liaison, US representative, registration and listing support