FDA Consultants - Medical Devices

Our FDA medical device consultants were involved with the regulation of devices while at the FDA.  We are able to help with appropriate medical device classification to determine the correct regulatory path required for your medical device.. Having the xFDA team working with you will help you through the process to deliver our services on time and within budget.

xFDA Medical Device Experts Have Wide And Varied Experience

Devices used in Neurosurgery, Neurology, and Psychiatry

Anesthesiology/Respiratory Devices

Orthopedic/Orthopedic Surgery Devices

Cardiovascular Devices, Drug Eluting Stents, Combination Products

Hardware and software design changes for high reliability Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRTs) Devices

Microelectronic Devices and Instrumentation

Digital Integrated Circuits

Analog Integrated Circuits

Communication Networks

Wireless Monitoring Devices

Random Signal Analysis

Fiber Optics

Solid State Devices

Biodosimetry Devices

In vitro Diagnostic Kits

Diagnostic Contrast Agents, Radiation Countermeasures, and Radioactive Drugs. 


Radiotherapy Devices

Radiotherapy Devices that include (a) Medical Linear Accelerator, (b) Radiotherapy Imaging Devices, (c) Patient Immobilization Devices, (d) Radiation Dosimetry Devices, (e) Brachytherapy Devices, (f) Radiotherapy Softwares, (g) Radiotherapy Accessories, (h) Anthropomorphic Phantoms for Radiotherapy


Radiology Devices

Radiology Devices that include (a) accessories to CT, MRI, Ultrasound, (b) Software, (c) Radiation Dosimetry Devices, (d) Anthropomorphic Phantoms for Radiology