How Do We Work
Our mission it to provide world class quality & regulatory support to medical device organizations
is our passion
is our passion
Helping you every step of the way
Quality system implementation for Start-Ups
Quality system maintenance for large organizations
Quality system project leadership and support for all organizations
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 audit preparation services
EU MDR transition planning and project management activities
FDA and EU submission support
Project Management and project engineering support services
Six-sigma project leadership and support
Lean manufacturing project leadership and support