BRIDGING THE GAP

Medical device manufacturing

Companies can lose years of time transitioning new medical devices into manufacturing. We provide bridge manufacturing services to help companies efficiently complete early builds while larger manufacturing partners develop lines for scale-up.

Want to explore how we can help you launch manufacturing?

DISCUSS YOUR PROJECT

FINDING RESOURCES AND OPTIMIZING COSTS

Supply Chain Development

We help components develop a distributed supply chain. Why is this important? It will show you the direct drivers of unit and capital costs. Moreover, it will reduce switching costs if you every need to alter your manufacturing strategy. We identify the right suppliers and optimize component and assembly costs throughout the process.

DISPOSABLE UNITS

Clean Room Manufacturing

We leverage our Class 10,000 (ISO 7) controlled environment room (CER) to perform builds of disposable devices such as surgical instruments, tubesets, and diagnostic cartridges. We are able to get low volumes of devices produced with the right build documentation in-place to support clinical studies and the V&V process.

ELECTROMECHANICAL SYSTEMS

White Room Manufacturing

We perform builds of electromechanical devices in white room manufacturing cells. This capability allows devices to be rapidly produced for research, early clinical evaluation, and the V&V process.

DO THE OUTPUTS MEET THE INPUTS?

Design Verification Testing (DVT)

We perform full design verification testing to confirm that the design outputs (drawings, specifications, product, labeling) meet the design inputs. We produce verification protocols, conduct the testing, and create comprehensive reports.

STERILIZATION, BIOCOMPATIBILITY, AND MORE

Process Validation Testing

We manage process validations, such as sterilization validation, biocompatibility validation, and shipping validation. We leverage our approved supplier list (ASL) to engage qualified suppliers for these processes, and integrate the results into the Design History File (DHF).

PREPARING FOR SUBMISSIONS

Regulatory Support

We manage the full Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) for our projects. We support the regulatory submission process for IDE, EFS, HUD, 510(k), PMA, IND, NDA, and ANDA.

DISCUSS PROJECT

Want to discuss your medical device manufacturing needs?

Schedule a 30-minute meeting with a senior member of the Archimedic team to explore how we can help you achieve your manufacturing goals.