Device History Record

As an FDA-registered manufacturer of finished medical devices Paramit maintains device history records for all products we build. For many manufacturers, device history records are expensive to create and maintain because of the oversight, enforcement, and administration involved. Even minor concerns such as storage space and paper costs contribute to the difficulty many companies experience when complying with the FDA requirement. At Paramit we have taken a fresh approach to the task, bringing innovation, cost reduction, significant improvement, and real usefulness to device history records.

vPoke Computer-Directed Assembly Technology

The standard process for creating and maintaining these records involves manual forms, checklists, signatures, and supervisor verification of operator tasks. Through our patent-pending computer-directed assembly technology called vPoke, Paramit has integrated all of these steps into an automated system, requiring no action on the part of a single individual.

All the information used in vPoke is a real time data extraction from our Production Data Management system, not a Word or PDF document. Before each sequence vPoke verifies the operator's qualifications and alerts a supervisor if the operator needs training or certification. During a sequence, vPoke records the duty cycles of the tools used, tracks the number of screws, washers, nuts, and other parts that were actually installed, and even measures the precise torque used for each individual screw. vPoke then validates that the operator performed the sequence correctly, captures a video image of the sequence, and stores the entire record in a relational database along with the actual sequence instructions, not a link to a Word, Excel, or PDF document stored elsewhere online.

FDA Compliance with Confidence

In the future, if a device fails in the field and the FDA wants to review the manufacturing process history for that device, we simply enter the product's serial number to access the entire device history record, including video images for each sequence. vPoke's automatically generated device history record goes well beyond the industry standard for compliance documentation, giving our customers confidence in Paramit's ability to handle any FDA inquiries.