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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.
Email: info@reuassociates.com
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