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Regulatory Insight has experience with a vast array of medical devices and IVDs;
a sample of which is listed below:


Acupuncture needles

Laser thermal keratoplasty devices

Anesthesia machines

Limb covers for pain

Auditory impedance devices

Liposuction lasers

Aversive conditioning devices

Liquid chemical sterilants/high level disinfectants

Biofeedback devices

Low-level light therapy devices

Biopsy needles

Magnetic resonance devices

Blood pressure monitors

Mammography equipment

Blood tubing and I.V. sets

Medical recirculating air cleaners

Body composition analyzers

Medical ultraviolet water purifiers

Bone grafting material

Nebulizers

Catheters

Opthalmic cameras

Cochlear implants

Opthalmic lasers

Colonic irrigation systems

Orthodontic devices

Condoms

Orthopedic devices

Contact lenses

Oxygen generators
Contact lens solution
Patient monitoring cables

Data storage and transmit devices

Penile implants

Dental curing lights

Powered muscle stimulators

Dental implants

Powered scooters

Dental lasers

Powered stretchers

Denture teeth

Resuscitators and ventilators

Dermal lasers

Retractors

Diagnostic electromyographs

Root apex locators

Dialysis equipment

Slitlamps

Digital thermometers

Sterilizer equipment

Drug-coated stents

Surgical drapes

Electronic stethoscopes

Surgical masks

Electro-surgical equipment

Surgical meshes

Examination gloves

Surgical gowns

Fetal Doppler devices

Surgeon’s gloves

Fluid-filled teethers

Sutures

Fluoroscopy equipment

Syringes (including safety syringes)

Functional electrical stimulation devices

TENS devices

Galvanic skin response measurement devices

Tonometers

Hair removal lasers

Ultrasound devices and probes

Hair regrowth lasers

Ultasound transducer covers

Heat lamps

Vaginal lubricating jellies

Hyperoxic breathing systems

Wheelchairs

Iontopheresis devices

Wound dressings

Infrared thermometers

X-ray equipment

Intraocular lens injectors

And many others …

In vitro diagnostic (IVD) devices (various)    
   

Medical Device
Regulatory Expertise


Principals
Sample Device Experience




Medical Device Regulatory Submissions

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Regulatory Insight, Inc. | 5401 S. Cottonwood Ct., Greenwood Village, CO 80121 U.S.A. | +1-720-962-5412 | info@reginsight.com

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