ARDL utilizes a proven, quality-based medical product development process to transform your product concepts into reality.
Our three-phase process has resulted in the successful commercialization of medical products for some of the largest medical device manufacturers in the world. Project managers at ARDL work with clients to develop project schedules that include well-defined tasks and milestones for each phase of development.
ARDL believes the most successful approach to product development begins with a thorough product definition based on your requirements. Engineers use the product definition as the basis for the development of system specifications, pre-production prototypes and test plans. As part a rigorous quality process, ARDL conducts functional reviews throughout product development to reduce overall time to market and to improve product performance, reliability and conformance.
ARDL provides regular data updates and reports so you can continuously track your project from start to finish. ARDL’s product development process incorporates the FDA requirements for medical device development.
Phase 1: Product Definition
- Quality Plan
- Product Functionality
- Product Material Specification
- Initial Risk Analysis
Phase 2: Product Development
- Concept Development
- Preliminary Product Review
- Detailed Geometry
- Critical Geometry Review
Phase 3: Implementation
- Test Plans
- Quality Plan
- Product Testing
- Prototype Building
If you would like more information about Medical Product & Materials Development Services please contact ARDL via email or by phone at (866) 778-ARDL or (330) 794-6600.
