Our medical device design and development work starts 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, developement, and testing with continuous analysis and discussion of results, improvements, and the critical paths toward a successful product launch.
We work with a network of surgical advisors, regulatory consultants, material and packaging experts, as well as manufacturing engineers to ensure that all technologies will be manufactured to the highest commercial standards.
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Overview
VIMedRx 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.
VIMedRx core area of product development and medical product design expertise include:
Financing Overview
VIMedRx provides financing solutions to develop your product ideas. We work with inventors to provide the budgets and capital needed to launch new products.
Contact us for confidential discussions on financing your product ideas and let us help turn your ideas into reality.
Design Overview
VIMedRx product development team works with clients to take medical device ideas from the initial concept through full product development, while maintaining the necessary FDA standards, certified tests, validation requirements, and documentation control. VIMedRx core area of product development and medical product design expertise include:
Design Assistance
» Medical Devices, FDA: Class I, II, and III |
» Catherter Development |
Documentation Assistance |
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» Technical Dossier needed to obtain FDA 510K, |
» FMEA (Failure Mode Effects Analysis) |
Testing Overview
VIMedRx product development team works with clients to take “medical device ideas” from the initial concept phase through full product development, while maintaining the necessary FDA stadnards, certified testing, validation requirements and documentation. VIMedRx core area of product development and medical product design expertise include:
Product Testing Assistance
» Certified Testing to meet ISO, CE, FDA, and UL Requirements
Animal Studies and Clinical Trials
» Assistance in setting up Animal Studies |
» System Training |
Manufacturing Overview
VIMedRx' core area of product development and medical product design expertise include:
Manufacturing Assistance
» Integration into Customer’s Manufacturing
» Custom Designed Manufacturing Test Fixtures
» Process Validation
» Screening of Contract Manufactures