We design, optimize, and maintain reliable and repeatable manufacturing processes
We design, optimize, and maintain reliable and repeatable manufacturing processes. We’re experts at designing, validating, and optimizing custom manufacturing processes for complex medical devices in adherence with quality and regulatory requirements.
Equipment & Tooling
We help select and design equipment and tooling for medical device manufacturing processes, including fixtures, precision tools, molds and dies, inspection and testing equipment, and automated manufacturing equipment.
Process Development
We help design and optimize medical device manufacturing processes that are scalable, reliable, and efficient.
Process Validation
We support comprehensive process validation programs that encompass Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These programs ensure a seamless transition of products into their commercial manufacturing environment.
Sustainment
We provide ongoing engineering and technical support for products that are in the mature stages of their lifecycle. This includes managing component obsolescence, implementing incremental improvements, ensuring regulatory compliance, and supporting software updates.
What's the ROI on Better Manufacturing?
Better manufacturing drives measurable outcomes. Organizations that accomplish improved manufacturing enhance quality through better product reliability, achieve lower costs and a more competitive cost of goods sold, and accelerate time to market for product launches and future product iterations.
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
Your innovationJust Mightchange the world. But is your manufacturing up to the task? We help you turnJust MightintoJust Mighty.
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