mdi ConsultantsHealthcare Industry Services
mdi Consultants offers a full range of services to the healthcare industry. Our services are focused on assisting medical device, pharmaceutical and food companies across the globe achieve regulatory and standard compliance with U.S., European and Canadian agencies and organizations.
Our approach to client service is to provide our clients with expert consultants who are armed with a proven and flexible consulting methodology. This approach enables us to provide you a customized service that meets your specific needs.
Please use a link on the navigation bar on the side of this page or use the links below to learn more about each of our service lines.
FDA Compliance
Our FDA compliance service line enables you to get your products to market quickly and to maintain your FDA compliance status.
Learn more ...ISO Compliance
ISO is a set of global quality standards that are geared to providing product or services companies a framework for achieving customer satisfaction through implementing a quality management system.
Learn more ...CRISIS INTERVENTION
Recently received a notice of a forthcoming FDA audit?
Received an FDA Warning Letter?
Thinking about implementing a Corrective Action or Product Recall?
HEALTH CANADA COMPLIANCE
mdi Consultants has extensive experience with various regulatory submissions to Health Canada and can assist with bringing your products to Canadian market.
Learn more ...CE Mark/MDD/IVDD
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.
Learn more ...IVDD
mdi Consultants, Inc. has helped many In-Vitro Diagnostic Device (IVDD) companies through a number of difficult research and development problems and issues.
Learn more ...HACCP
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.
Learn more ...U.S. DESIGNATED AGENT
The U.S. FDA has approved regulation that ALL Foreign Establishments whose products are imported or offered for import into the United States MUST register with the FDA and MUST identify a United States Agent.
Learn more ...BUSINESS DEVELOPMENT
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 largest integrated delivery networks.
Learn more ...REIMBURSEMENT CONSULTING
Each year in the United States over 5 billion claims are filed for insurance payment. The vast majority of individuals treated by physicians or other qualified providers have some portion of their medical expense covered by government or private insurance.
Learn more ...OTHER BUSINESS SERVICES
mdi Consultants has on staff a number of seasoned industry executives that have led organizations through tough and challenging business issues.
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