Auditing

• Processed Based Auditing
• FDA QSR
• Warning Letter
• ISO 13485:2003
• EN MDD/93/42/EEC

Do you know if you are prepared for an FDA audit?
Are you confident that your suppliers/contractors are meeting their obligations? Are your internal processes being followed?

Many organizations do not have the time or experience to conduct audits. Many do not understand how to handle a FDA inspection. Our consultants are experienced in leading audits and managing audits from regulatory agencies and standards organizations.

Our auditing services:

• Help you prepare for an FDA Inspection
• Develop your internal and supplier program
• Will serve as your Internal Audit staff (contracted)
• Conduct Gap Analysis
• Manage your ISO certificate audits
• Conduct follow-up audits to Corrective Actions for Warning Letter improvements
• Are conducted in accordance with MDD, ISO 13485,and QSRs
• Will conduct Supplier/Contractor audits. We give you confidence that your suppliers are meeting their commitments.
  

Email: info@reuassociates.com