• Quality Systems
• Regulatory Compliance
• Risk Management
• Sterilization
• Cleanrooms & Controlled Environments
• Clinical Services
• Biocompatibility
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• Process Validation

Services: Quality System Implementation

A robust Quality System is integral to ongoing regulatory compliance and smooth inspections and audits.QA Consulting will implement a customized Quality System meeting the requirements of 21CFR and ISO 13485 to enable a company to meet the requirements for the US, Canadian, and European CE Marking.

• Design Control -
  Outsource your design history file generation, design verification and validation protocols and design reviews to us to ensure compliance is achieved.
  
  
• Quality System Audits -
  Our Certified Auditors can conduct internal or supplier audits. Our team has performed over 100 audits to ensure compliance with 21 CFR 820, ISO 13485, CFR 21 Part 11, 21 CFR Part 58 or ISO 17025.
  
  
• Validation
  • Process Validation
    
    
• Compliance Training
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