Development

Elcam and E3D have over 35 years of experience in medical device development, managing the process from understanding marketing requirements and engineering feasibility through the various elements of invention and patent registration. E3D employs an established methodology that incorporates stage gates of preliminary, detailed, and critical design reviews (both for the product and the manufacturing process), risk management through the development process, product verification involving both internal and external laboratories, biocompatibility, shipping tests, standards tests, formative and summative usability studies, process validation tests and design transfer to manufacturing according to well-established processes.
With a flexible and responsive approach, E3D can adjust project phases and timelines according to customers’ internal and external constraints and needs.