MDVentures Solution #100

How MDVentures assisted a startup company develop and implement a regulatory
strategy for a new robotic surgical system.

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Situation:	The company needed to identify a regulatory strategy for clinical trials and product submission of a new and innovative product. The project had to be performed within a limited budget without a Significant Risk IDE or lengthy PMA submission
Problem:	There was no clear precedence for the application and the client had insufficient regulatory staffing to support the project.
Solution:	Working with the development team, MDVentures developed a regulatory plan and presented a proposal to the FDA that resulted in a shortened clinical trial and a 510(k) product submission. MDVentures completed the submission work and received 510(k) clearance within eight months of the project start date.
Benefit:	Reduced regulatory costs for the project and availability of product for sale on schedule.

 

 

 

 

 

 

 

 

 

 

 

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