MDVentures Solution #400

How MDVentures assisted a European manufacturer of arthroscopic surgical
equipment to enter the US market and form a profitable US division without
establishing a formal local marketing, sales and distribution network.

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Situation:	A medium-sized European medical device manufacturer wanted to expand its business into the US but did not have the budget for a US marketing and sales operation. Their goal was to establish Internet sales of their products with shipments emanating from the United States; however, their products were not FDA compliant.
Problem:	The company had neither expertise nor knowledge of the regulatory environment in the United States.
Solution:	MDVentures worked with the client to establish a United States corporation based on Internet sales and distribution, with an FDA compliant quality system. MDVentures assisted in successful product submissions through the 510k process and FDA registration of the resulting company.
Benefit:	The company's US operations are now highly profitable with minimal staffing required to maintain compliance with all FDA requirements for controlled medical device products. Retaining MDVentures as their USA regulatory agent eliminated the need for a full time local regulatory staff.

 

 

 

 

 

 

 

 

 

 

 

 

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