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MDVentures Solution #200
How MDVentures assisted a five person manufacturing company implement a
medical device compliant quality system.

Situation: 

A startup company manufacturing chemical sensors needed a
medical device compliant quality system to market their
products to OEM customers in the US and Europe

Problem: 

The Company was small and required a quality system that
could be maintained by the existing staff.

Solution: 

Worked with existing staff to create a multifunctional form
based quality system with most procedures incorporated
into the company's quality manual.

Benefit: 

Without adding additional staff the company met FDA Quality
System Requirements and received ISO and EN 46000 certification.
 
 

 

 

 

 

 

 

 

 

 

 

 

 

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