Upon project approval a development agreement is executed, which allows us to put your product through our proprietary product development engine, which we’ve painstakingly developed and refined over the last two decades. This ensures smooth passage through the development process and future regulatory hurdles. Our engineers employ an agile method of product development involving rapid prototyping, close client collaboration, continued iteration and refinement until both parties agree that near-perfection has been achieved.
We know that creating engaging products and user experiences takes a well-rounded, seasoned, and multi-disciplinary team working side-by-side. Our open office development environment enables high levels of communication and interaction, achieving seamless and efficient product development.
Our process, which is in compliance with FDA’s Design Controls, ISO 13485:2016 and ISO 14971, allows us to create and manage Design History Files, while helping our clients create their own quality management systems.
Our product development services culminate in fully developed and validated medical devices. We provide clients full documentation, including design document control, risk management files, design history files, device master records, and quality system guidance documents.