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US Designated Agent Services
The FDA requires the use of a U.S. Agent to the Food and Drug Administration for all companies and manufacturers that...
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FDA Compliance for Medical Devices Companies
Our FDA compliance service line enables you to get your products to market quickly and to maintain your FDA compliance...
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ISO Compliance and ISO Standards
ISO is a set of global quality standards that are geared to companies providing products or services as a framework for...
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Health Canada Compliance
Health Canada Compliance for Medical Devices and Health Care Products Marketing Medical Devices in Canada, the...
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Crisis Intervention
Are YOU presently concerned or involved in any of the following? Recently received a notice of a forthcoming FDA...
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CE Mark / MDD / IVDD / AIMDD
CE Mark is the European Community requirement for selling devices within Europe. This means that without the CE Mark...
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In Vitro Diagnostic R&D
mdi Consultants, Inc. has helped many In-Vitro Diagnostic Device companies through a number of difficult research and...
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HACCP Consulting Services
HACCP is a tool that was originally developed for the seafood industry to determine potential hazards in your...
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Business Development Consulting
Mdi Consultants offers a new full turn key business development solution to medical device manufacturers who need and...
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Codes, Codes, and Codes
FDA Releases Draft Guidance on Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations
FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency
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