REU Associates

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Office: 440.953.9789
Fax:     440.953.9789
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Design Development Project Management

REU Associates Inc. will provide project management for your design development to assure compliance with FDA and international regulatory requirements. Our project management services provide:

Option 1

  • Project Assessment & Planning
  • Resource Planning & Management
  • Risk Management & Contingency Planning
  • Validation Planning, including procedures and protocols
  • Clinical Test Plans
  • Project Phase & Product Design Reviews
  • Manufacturing Planning
  • Documented design transfer to manufacturing
  • Design history files

Option 2

  • Entire project assessment and planning, from concept to manufacturing
  • Clearly defined project deliverables
  • Management of key project resources
  • Risk management & contingency planning
  • Development of validation and clinical test plans
  • Development of manufacturing and post market surveillance plans
  • Implementation of procedures, protocols, documents and records
  • Project Phase & Product Design Reviews
  • Design History Files, Technical Files, FDA Submissions, etc.

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