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 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