RCRI - Medical Device CRO    
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ISO 9001:2000 CERTIFIED SERVICES:

 
Regulatory Affairs Regulatory Affairs
Clinical Trial Design & Management Clinical Trial Design & Management
Database Development & Compliance Database Development & Compliance
Reimbursement Strategy and Implementation Reimbursement Strategy and Implementation
Health Economics Health Economics
Quality Systems & Compliance Quality Systems & Compliance
Biostatistics Biostatistics
Venture Capital Due Diligence Venture Capital Due Diligence

 

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Medical Products Quality Systems and Compliance Consulting Services

QUALITY SYSTEMS & COMPLIANCE

Corrective Actions

In the event that corrective actions are needed, RCRI® will develop a strategy and implement a plan to conduct:
  • Safety alerts.
  • Product recalls.
We will also prepare responses to:
  • Warning letters
  • U.S. FDA 483 observations.
  • Notified body nonconformances.
 

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