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About Us

Medical Device Quality Management Systems that are Efficient, Effective, Sustainable, Usable, and Compliant. Winovia can help you get there.

Consulting and training specialties include:

  • Leading remediation projects; functioning as the acting or interim Director of Quality Systems
  • Product life cycle management; new product development processes; Design for Six Sigma, Design Controls
  • Manufacturing and operational excellence, Six Sigma and Process Validation
  • Supplier Controls / Supplier Quality
  • Corrective Action and Preventive Action (CA/PA)
  • Strategic Technology Road-mapping
  • Quality Management Systems and good manufacturing practices (FDA 21 CFR Parts 210, 211, 820; ISO 13485; ISO 9001; ISO 16949; ICH Q7 and Q10)
  • Change Control
  • Risk Management (ISO 14971, ICH Q9, HACCP, FTA, FMEA)
  • Change Management
  • Project Management
  • Plastics in Medical Devices

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