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.
  
  Email: info@reuassociates.com