All businesses are unique — consistency and reliability are critical to ensuring quality. Whether you are part of an emerging company or a long-established multinational corporation, Avania can ensure your quality system fits your organizational structure.

  • Development of quality management systems to meet U.S. quality system regulations contained in the Code of Federal Regulations and the requirements of ISO 13485, ISO 9001, CMDCAS (Canada), and TGA (Australia)
  • Management and organization responsibility
  • Quality manual preparation
  • Personnel training and risk management
  • Design and document controls
  • Purchasing and vendor controls
  • Identification and traceability
  • Inspection and calibration
  • Production and process controls
  • Nonconforming materials
  • Packaging and labeling control
  • Development of corrective and preventive actions (CAPAs)
  • Handling, storage, distribution, and installation
  • Process validation
  • Sterilization
  • Product release
  • Complaint handling and product returns
  • Field corrective actions
  • Management review
  • SOP implementation and employee training
  • CAPA processes
  • Quality system audits
  • Quality system maintenance
  • Notified body selection
  • ISO 13485 certification
  • Effective gap analyses of existing quality systems and compliance throughout product life cycle 
  • Assessment of your internal quality system controls and your sites’ data collection  
  • Audit preparation (FDA, notified body, etc.)
  • Internal and external auditing including:
    • ISO 13485/9001
    • Quality system regulation (QSR)/current good manufacturing practices (cGMP)
    • Good clinical practices (GCP)
    • Good tissue practices (GTP)
    • BIMO preparatory and investigative site audit
    • Vendor and supplier audits
    • Institutional review boards (IRBs)
    • Good laboratory practices (GLP)
    • EU Medical Device Directive and Regulation
    • Medical device reporting/vigilance reporting systems
  • Mock regulatory inspections
  • Training to prepare investigator sites for regulatory inspections
  • Assistance with responses to inspection findings

Your product is important, and it takes a team with quality management expertise to move it forward. It Takes Avania.

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