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mdi Consultants, Inc. has been serving the medical device industry for over 25 years. We have extensive experience in helping medical device companies across the world successfully enter and obtain market approval in the United States, Europe and Canada. Whether it is for 510(k) submission, cGMP compliance, ISO 13485 compliance or CE Mark approval, mdi Consultants, can provide you customized services.

We have served hundreds of medical device companies on all the issues above. You can browse our client list or view our client testimonials for more information on the results we have delivered for other companies. Our medical device experience covers some of the following product areas:

Biologically-based devices
Biopsy Equipment
Blood Pressure Monitors
Catheters (cardio, urological, other)
Condoms (latex, other synthetic)
Contact Lenses (and accessories)
Dental
Defibrillators
Dialysis Equipment
Disposal instruments
ECCP Endoscopes and Assorted Accessories
Examination Gloves (latex, powder-free, chlorine-free, synthetic)
Gamma Knives
Hospital Equipment
Implants
In-Vitro Diagnostics - HIV, Elisa Assays, Blood Tests, Urine Tests and Instrumentation
IOLs
Lasers
MRI Equipment
Nebulizers
Needles
Needle Destruction Devices
Orthopedic Instruments and Equipment
Oxygen Concentrators
Peak Flow Meters
Polymers
Radiation treatments and accessories
Rehab Equipment
Surgical Instruments
Surgical Kits
Surgical Gloves, gowns, masks
Vac-u-tainers
Wheel chairs and scooters
X-Ray machines and films

For medical device companies, we offer the following services:

• FDA Compliance
• ISO Compliance
• Crisis Intervention
• CE Mark/MDD/IVDD
• In-Vitro Diagnostic Research and Development
• HACCP
• U.S. Agent (for non-U.S. companies)

For more information about the services we offer medical device companies, please visit our Services section by clicking on the Services link on the top navigation area.

The mdi news and information section provides information links to all you need to stay up-to-date on industry information. You will find our Insight Report, which includes commentary and analysis on important regulatory issues. We also have information on FDA recall and updates as well as a comprehensive list of important industry links.

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