Paramit is an FDA-registered and ISO-certified manufacturer of medical devices and instrumentation.We regularly examine and assess systems and records to confirm that our company, products, processes, and documentation are in compliance with 21CFR820 and ISO 13485 standard.
Device History Record with vPoke
Traditionally, a device history record is associated with significant costs in terms of human capital, space, process overhead, and even paper. Seeing an opportunity for innovation, Paramit created a patented, computer-directed assembly technology called vPoke. vPoke not only virtually eliminates manufacturing defects from the assembly process but also automatically creates a device history record in real time as each sequence is completed.
If in the future a device fails in the field and you want to review the manufacturing process history for that device, we simply enter the product’s serial number to access and automatically generate the entire device history record, including video images for each sequence. Going well beyond the industry standard for compliance documentation, vPoke lets us handle any inquiry for our clients.