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?BOOK STRATEGY CALL
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.
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.
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
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.
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.BOOK STRATEGY CALL