ADVERTISEMENT
 
 

Crisis Intervention

by MDI Consultants Inc.

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
Undergoing a Clinical Trial Investigation
It is important that you prepare and respond to each of these situations carefully and thoughtfully. Failure to properly act in these situations could possibly result in your business being shut down, criminal/civil actions being filed against you or your company, and/or huge financial losses. We have seen many companies proceed without guidance and have ended up wasting a lot of time and money by not involving expert assistance during these critical situations.

mdi Consultants is the recognized industry leader in assisting healthcare companies out of crisis situations. Since time is critical, mdi Consultants has created an emergency hotline, which can provide you some initial assistance in understanding what is going on and how to proceed.

Our emergency hotline phone number is +1 (516) 482-9001. You can also send us an e-mail at crisis@mdiconsultants.com

This initial consultation of up to one hour will be done at no charge. After the first hour, a fee will be discussed and approved. If you are not satisfied with mdi's services, you may cancel at any time and pay for only the time you used.

More Products from MDI Consultants Inc.

 
Available from: MDI Consultants Inc.
Foreign companies should be prepared for FDA inspections of the operations. Having a consultant on site with extensive FDA experience is the best way to go. The second best way to be prepared for an...Read More
Available from: MDI Consultants Inc.
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 2...Read More
Available from: MDI Consultants Inc.
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...Read More
Available from: MDI Consultants Inc.
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...Read More
Available from: MDI Consultants Inc.
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...Read More
Available from: MDI Consultants Inc.
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...Read More
Available from: MDI Consultants Inc.
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...Read More
Available from: MDI Consultants Inc.
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...Read More
Available from: MDI Consultants Inc.
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...Read More
Available from: MDI Consultants Inc.
Prepare 510(k)s for new devices planned for market and submit amended 510(k)s for changes in devices already being distributed.

Obtaining FDA interpretation on device problems while...Read More
ADVERTISEMENT