CyndRx Projects
Our medical device development and design work begins with planning to ensure that the process will be efficient, results oriented, time-sensitive, and able to meet all quality and performance objectives.
After internal approvals, we move through several stages of research, development, and testing with continuous analysis of results, improvements, and critical paths toward a successful product launch.
We work with a network of surgical advisors, regulatory consultants, material and packaging experts, and manufacturing engineers to ensure that all technologies are brought to the market with the highest commercial standards.
Overview
CyndRx product development team works with clients to take medical device ideas from the initial idea through full product development, while maintaining the necessary FDA standards, certified tests, validation requirements, and documentation controls.
CyndRx core area of product development and medical product design expertise include:
Design
CyndRx product development team works with clients to take medical device ideas from the initial concept through full product development while maintaining the necessary regulatory standards, certified tests, validation requirements, and documentation control.
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Testing
Product testing begins with component testing at the initial concept phase and continues through full product development while maintaining the necessary regulatory standards, certified testing, validation requirements and documentation.
Product Testing Assistance
- Certified Testing to meet ISO, CE, FDA, and UL Requirements
Animal Studies and Clinical Trials
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Manufacturing
Manufacturing Assistance
- Integration into Customer’s Manufacturing
- Custom Designed Manufacturing Test Fixtures
- Process Validation
- Screening of Contract Manufacturers
Financing
CyndRx projects are funded internally. Prior to project launch, schedules and budgets are vetted and approved. Monthly review reports compare actual performance against the plan allowing for appropriate adjustments.
CAUTION: Investigational Device. Limited by Federal (or United States) Law to Investigational Use.