Clinical Engineering Phase

Manufacturing Capacity Accommodates Flexibility

Millar's ultimate goal at the Clinical Engineering stage is to meet your initial production demands for validation testing and get your device through regulatory submission and approval as efficiently as possible. In fact, our Clinical Engineering and Manufacturing Development phases can overlap during the OEM Solutions Integration Process based on your needs and timelines. Millar's flexible manufacturing capacity allows us to scale up or down, from early pilot builds to large clinical trial volumes, depending upon your specific needs.

Validation and Testing Volumes Finalize Processes

At this point in the process, you'll have one or more production lines dedicated to your clinical product builds and manufacturing your product to production build standards. All steps and parts of your production process are finalized with product documentation released and suppliers confirmed. If required, Millar can take full responsibility for the supply chain and leverage our long-standing supplier relationships.

Millar can build quantities to meet customer testing purposes, including biocompatibility, electrical safety, and animal studies, ranging from hundreds of units to thousands, based on our partner's own validation requirements and those of the regulatory agencies. When you get to clinical trials, we'll be prepared whether you need units for under 100 patients or more than 1,000.