MEDICAL DEVICE OUTSOURCING SOLUTIONS
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Products & Services
Quality Management Systems
  • Start-up systems
  • System clean-up
  • New standard adaptation / implementation
  • Training programs
  • Document control
  • Configuration management
Compliance
  • Mock audits (including PAI)
  • Audit findings resolution
  • Compliance comprehension
  • Risk management

Regulatory

  • Regulatory Comprehension
  • Testing / 510k / PMA Submission
  • Submission Preparation
  • Submission Review
Contract Engineering & Manufacturing
  • Design
  • Development
  • Process Development
  • Validation / Qualification

Supply Base Management

  • Assessment / Qualification
  • Auditing & Monitoring
  • Contract Negotiation & Preparation





  • Design Control Management Software
  • Online Quality System & Document Store
  • Specialized Training Modules