Healthcare Industries: Medical Devices
mdi Consultants, Inc. has been serving the medical device industry for 39 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:
Blood Pressure Monitors
Catheters (cardio, urological, other)
Condoms (latex, other synthetic)
Contact Lenses (and accessories)
ECCP Endoscopes and Assorted Accessories
Examination Gloves (latex, powder-free, chlorine-free, synthetic)
In-Vitro Diagnostics – HIV, Elisa Assays, Blood Tests, Urine Tests and Instrumentation
Needle Destruction Devices
Orthopedic Instruments and Equipment
Peak Flow Meters
Radiation treatments and accessories
Surgical Gloves, gowns, masks
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
- U.S. Agent (for non-U.S. companies)
For more information about the services we offer medical device companies, please visit our Services section.
The mdi NEWS & INFO 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.