Regulatory Compliance / Quality

RCCG Quality and Compliance experts provide current knowledge and extensive past experience  to ensure the regulatory compliance of your company.

RCCG regulatory compliance and quality experts:

  • Evaluate current quality systems
  • Assist clients with identification of compliance issues
  • Provide guidance on remediation of issues and regulatory actions
  • Perform compliance services including:
    • Guidance and preparation for Medical Device Single Audit Program (MDSAP) for US, Canada, Japan, Brazil and Australia medical device/IVD
    • Quality Management Systems guidance on implementation, executing and oversight for current regulatory requirements including, but not limited to GMP, JGMP, CMDCAS, QSR, and ISO 13485 compliance
  • Provide expertise in the range of validation activities
  • Provide services as US Agent
  • Assist domestic and international facility registrations and product listings
  • Assist ongoing post-market surveillance services