Our Expertise

Device & Regulatory Experience

FELLMAN DEVICE GROUP EXPERTISE

Mr. Fellman is a highly skilled biomedical engineer and FDA regulatory expert with unusually diverse device experience obtained during his 15-year career as a reviewer, team lead, branch chief, deputy director, and Director within the CDRH Office of Device Evaluation (now OPEQ).

His knowledge of devices, staff, policies, and precedents in different OPEQ offices will provide focused advice to help you navigate the FDA process and get your devices efficiently to the US market.

Diverse Device Experience

Cardiovascular Devices

Implants & Stimulators
Therapeutic Devices
Diagnostic Devices & Sensors
Imaging Catheters
Software Devices (SaMD)
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General Surgery Devices

Robotic Assisted Devices
Energy Devices
Surgical Instruments
Aesthetics Devices
Cancer Diagnostics / Treatment

OTHER DEVICES INCLUDING

Anesthesia Devices
Respiratory Devices
Injectors / Drug Delivery
Catheters / Sheaths
Leads, Guidewires, Electrodes

Extensive Regulatory Expertise

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FDA Programs

Digital Health
Breakthrough / STeP Devices
FIH / EFS Cinical Studies
Real World Evidence / PRO
Humanitarian Use
Combination Products
Cybersecurity

New Technology

Medical Device Apps
AI and Learning Algorithms
Telehealth & Remote Monitoring
OTC / Wellness Devices
MR Compatibility
Modeling / Simulations
Reprocessing
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Supporting Evidence

Risk/hazard Assessments
Bench Testing
Software Validation
Animal Studies
Human Factors Testing
Biocompatibility & Sterilization
Pre/Post-market Studies