Medical Device Contract Manufacturing

All new projects begin with a sit-down with Ranfac’s senior leadership. Here, we can get to know each other and determine if there is mutual interest in partnering. By having a clear understanding of your needs, we will determine the best solutions to get your product to market as efficiently as possible. Every device has its own unique challenges. That’s why Ranfac does not operate under a one-size-fits-all model.

Once we understand the scope of your project, we will build out a project plan broken down into our 4-phase development process, detailing expected development timelines, estimated costs for tooling, engineering and regulatory submissions.

With the plan approved, your dedicated project manager will be assigned as your partner from design through launch to manage your design history file (DHF) and will work closely with Ranfac’s production and quality teams to ensure your device is designed for ultimate efficiency and consistent efficacy.

Ranfac will compile documentation packages and other relevant paperwork to make your regulatory filing go smoothly. Ranfac can work on your behalf with the FDA and other international regulatory bodies to submit for applicable regulatory clearances. Note that Class I devices do not require FDA submission although they do require the same level of documentation and testing as a Class II device.

Once the Alpha phase has been reached and the product has been released to manufacturing, Ranfac will launch at your pace. We understand it takes time to get a new product off the ground, which is why we offer low minimum order quantities.

We look forward to growing together, which is why we are constantly reinvesting in our infrastructure and technologies to stay ahead of future demand.