Product Introduction

We prepare processes and devices for commercial manufacturing

 

We prepare processes and devices for commercial manufacturing. We finalize tooling, order raw materials, and complete process development and validation programs. 

Manufacturing

We develop custom manufacturing solutions that optimize efficiency, enable innovation, and deliver long-term success and stability. We manufacture and assemble medical devices, components, and liquid media. We are an ISO 13485-certified and FDA-registered medical device contract manufacturer. 

Material Sourcing

We source, select, and manage suppliers of equipment, tooling, raw materials, components, and services, and ensure seamless, uninterrupted supply chains.

Inspection

We support inspection procedures to ensure product quality and regulatory compliance, including raw material, in-process, and finished product inspection, as well as environmental monitoring, and routine calibration and maintenance of equipment. 

Testing

We provide testing support during process development and validation, and commercial manufacturing, including biocompatibility, feasibility, verification and validation testing. We utilize external testing laboratories when necessary.

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.

Documentation

We provide comprehensive documentation to support the quality and regulatory requirements of process development and validation, and ongoing manufacturing. This includes process verification and validation reports, DHF/DMR/DHR records, procedures and work instructions, supplier audit records and certifications, and corrective and preventive actions records. 

Supplier Management

We provide supply chain management support for biomedical devices, components, and liquid media. Our supplier management activities include material sourcing, supplier selection and qualification, performance monitoring, and risk management in accordance with appropriate quality and regulatory requirements. 

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

 

Content Card - Just Mighty - Build - Two Color - Full (1920 x 1080)
Logo - Just Mighty - White Logo (400 x 400)

Your innovation Just Might change the world. But is your manufacturing up to the task? We help you turn Just Might into Just Mighty.