Borinquen Quality Support leverages the strong tradition of medical device manufacturing and engineering in Puerto Rico along with technological advancements in remote work connectivity to provide medical device organizations across the world with top tier quality and regulatory support at a fraction of the price of other major life sciences consulting agencies. 

Regulatory Market Access Support 

Meeting the required regulatory requirements are essential for an organization’s survival. There is no legal market access without regulatory approval. The regulatory landscape is convoluted and always changing so a sound regulatory strategy is a fundamental component of any business plan.  Our team of regulatory experts can tailor a regulatory strategy to mitigate risk and minimize cost so that you can a enter the market before your competitors. Services offered include: 

• FDA PMA  
• FDA 510(k) 
• FDA De Novo 
• EUMDR 
• MDD/EUMDR Transistion