Manufacturing Transfer
Transitioning your validated device into its commercial manufacturing environment with efficiency and effectiveness.
Commercializing a medical device requires more than a validated device—it requires a reliable production process and a seamless transition from development. Manufacturing transfer is one of the most operationally complex moments in a device's commercialization program, and the quality of the transition has a tremendous impact on commercial success. We transition your validated device into its commercial manufacturing environment with efficiency and effectiveness.
We finalize tooling, complete process validation, establish the device master record, and coordinate every element of your transition to commercial manufacturing—so your production process is built to perform.
Our Approach
We provide the manufacturing expertise and capabilities biomedical innovators need
We provide the expertise and capabilities necessary to manufacture with reliable product quality, competitive costs, and efficient time to market. We bring deep expertise working with biomedical devices, components, and liquid media across clinical applications.
Discovery
We begin by understanding where you are today, what you already have in place, and your future objectives. We accomplish this in one or two discovery meetings.
APPROXIMATE TIMING: 1-2 DAYS
Assessment
We create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives.
Approximate Timing: 1 week
Statement of Work
We develop a detailed statement of work for the first phase of your project. The statement of work outlines the project timeline, deliverables, cost, and key milestones.
Approximate Timing: 1-2 weeks