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The FDA requires the use of a U.S. Agent to the Food and Drug Administration for all companies and manufacturers that do not have a presence in the United States. A U.S. Agent to The Food and Drug Administration (FDA) must be a resident of the United States, or have a physical place of business... Read more »
Our FDA compliance service line enables you to get your products to market quickly and to maintain your FDA compliance status. As professional consultants to the healthcare industry for over 3 decades, mdi has helped hundreds of companies to achieve and maintain their FDA compliance. What are... Read more »
ISO is a set of global quality standards that are geared to companies providing products or services as a framework for achieving customer satisfaction through implementing a quality management system. The ISO set of standards have become an important mechanism to allow companies to inform their... Read more »
Health Canada Compliance for Medical Devices and Health Care Products Marketing Medical Devices in Canada, the manufacturers, private labelers, importers, and distributors of Medical Devices are required to meet all requirements of the Canadian Federal Regulatory Authority, and its agency... Read more »
Are YOU presently concerned or involved in any of the following? Recently received a notice of a forthcoming FDA audit Received an FDA Warning Letter Received non-conforming observations from an FDA audit (483) Thinking about implementing a Corrective Action or Product Recall... Read more »
CE Mark is the European Community requirement for selling devices within Europe. This means that without the CE Mark you cannot sell your medical device within the European Community. The CE Mark represents compliance with a specific device directive which can be achieved through self assessment... Read more »
mdi Consultants, Inc. has helped many In-Vitro Diagnostic Device companies through a number of difficult research and development problems and issues. Can you respond “yes” to any of the following questions: 1. Do you lyophilize your calibration controls, antibodies or any other reagents? 2.... Read more »
HACCP is a tool that was originally developed for the seafood industry to determine potential hazards in your production process that might critically effect the quality of your end products. At the current time, HACCP is required for the food industry, however, the FDA has made initial strides... Read more »
Mdi Consultants offers a new full turn key business development solution to medical device manufacturers who need and seek to have business development meeting opportunities facilitated at the highest levels within US based provider organizations including but not limited to some of the nation’s... Read more »
Current Procedural Terminology (CPT Codes) and ICD-9 Codes Level I Codes (Current Procedural Terminology)are medical services and procedures codes used by physicians filing for payment for services rendered. The CPT Codes are maintained and republished annually by the American Medical... Read more »
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