Products by mdi Consultants, Inc.

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FDA Compliance for Medical Devices Companies

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 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 Compliance

ISO Compliance

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

Crisis Intervention

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 / MDD / IVDD / AIMDD

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

In Vitro Diagnostic R&D

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 Consulting Services

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

Business Development Consulting

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

Reimbursement Consulting

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

Clinical Trial Management

Our services include developing the clinical protocol, setting up and interacting with the IRB (Institutional Review Board), submitting the IDE (Investigational Device Exception), recruiting and working with the investigator, monitoring the trials, data gathering and analysis, project... Read More

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