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.
Nonconformance Response Services
Disciplinary actions from a regulatory agency can have severe consequences such as fines, loss of market access, and even incarceration. Our team has a wealth of experience interfacing with regulatory agencies to ensure that any nonconformances are addressed adequately and in a timely manner. Nonconformance Response services are offered for the following types of Regulatory Agency Nonconformances:
- FDA Warning Letter
- FDA 483
- Notified Body Major Nonconformance
- Notified Body Minor Nonconformance
