Smart ideas need a smart approach because invention has value only when it connects meaningfully to the marketplace. Our goal is to create products that are breathtakingly beautiful, commercially game-changing and functionally elegant.
Our modified stage-gate process integrates strategy, research, marketing insight, design innovation, engineering with customizable levels of documentation support to drive the development of break-out retail products as well as innovative medical devices including certification compliant documentation. Contact us to learn more about our integrated development process.
Medical Device Design, Health + Wellness Programs
Medical and health programs requiring certification have special needs in terms of process documentation and testing. We can support FDA compliance with design plan, design controls, documentation, requirements changes, validation etc. Modern Edge also has experience supporting programs with UL, CE and with most other certification agencies. We can support ISO compliant manufacturers, and certain types of medical research. Our experience in the medical field ranges from physical devices, such as stent placement devices and diagnostics equipment, to experience and service design in medical centers and in the field. Among some of the features of our integrated process:
- Synchronizing Requirements Management and Design Controls
- Requirements Management Process to prioritize Essential Requirements and Critical to Quality Requirements
- Appropriate elaboration on requirements to ensure ease of development and testing
- Proper evaluation and acceptance of requirements.
- Bi-directional traceability of requirements
- Management and control of requirement changes.
- Selection of requirement metrics