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Medical Device Engineering Services
Regulatory Documentation Services
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Toltec International Inc International Projects / Programs
Toltec International Projects
Toltec International has extensive experience in product development projects that are international in scale. Toltec has particular international expertise in project management, remote site software development, technology transfer, international standards, conflict resolution, cultural techniques, communication techniques, and product development regulatory strategies. Toltec's unique capabilities will give you an edge in developing your product for the global marketplace.
Services include: Project consulting
- Design customization for US market
- Independent assessments for international scale projects
- Hands on consulting for your international project
- Techniques for software development and testing on an international scale
Market and Regulatory Consulting
- Premarket assessments for product
- Product benchmarking
- Device classification, 510K development, PMA development, CE marking
- Determine international standards and requirements
- Write protocols and provide oversight for market, field, or clinical trials
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