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. 

Third Party Audit Preparation Services

Third party audits by either a regulatory agency or a certifying organization can be nerve raking. Let us help reduce the stress of these situations by lending our expertise. The BQS systematic three step audit preparation process will position your organization for the best possible audit outcome.  Audit preparation services are offered for the following types of audits: 

• FDA PMA 
• FDA Routine  
• MDSAP 
• ISO 13485 Initial Certification 
• ISO 13485 Recertification 

Auditing Services

A skilled auditor is the first line of defence in identifying a problem before it becomes a problem. Our qualified and certified auditors will assess you systems and leave you with the peace of mind that any systemic risks have been identified. Auditing services offered include: 

• Internal QMS Audits 
• Internal Process Audits 
• Supplier QMS Audits 
• Supplier Process Audits