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MDVentures Solution #210

How MDVentures assisted a medical device company complete process
validations and meet all requirements stipulated for removal of an FDA
mandated Consent Decree.

Situation: 

The company was operating under a Consent Decree for failing to follow
drug regulation requirements for quality systems related to combination
devices and process validation.

Problem: 

The company was unable to distribute or sell product in the USA under 
restrictions emanating from the Consent Decree. Additionally,  
 their products did not conform to MDD requirements and lacked 
CE marking, resulting in severe loss of revenue. Staffing was
minimal due to financial problems.

Solution: 

Working with the FDA District Office MD Ventures developed a
validation and quality system implementation plan and completed all
requirements for FDA compliance. MD Ventures also identified a
European Notified Body and worked with them to bring all quality
system elements and medical device product performances into
compliance with established standards, resulting in CE marking.

Benefit: 

The company was able to begin sales and distribution in the USA
and in Europe, resulting in improved cash flow. Staffing was increased
and the company was able to continue operations until the Consent
Decree was ultimately satisfied.

 

 
 

 

 

 

 

 

 

 

 

 

 

 

 

To find out how MDVentures can provide solutions for your company
call (909) 506-2674 or email: solutions@mdventures.net