FDA approval is essential to getting medical products to market, and the manufacturing practices required to support these products are exacting. We have developed both strategic alliances with MedTech Development and end-to-end internal processes to manage medical manufacturing.  Paramit has also maintained ISO 9001:2000 and 13485:2003 registrations, is fully FDA/GMP certified, and currently manufactures products for a broad base of medical customers.

Component Traceability

A comprehensive tracking system records specific purchase order, component manufacturer, and manufacturers lot code information for FDA traceable components.  All FDA records are stored in a fireproof cabinet.

Training Certifications

Specialized training has been conducted for operators to assemble medical products. Only medical certified assemblers and technicians perform work on these products.

Custom Software Solutions

Custom software solutions have been developed to manage medical products throughout the development and manufacturing processes. Automated SMT Pick-and-Place BOM download, on-demand label printing, on-line Manufacturing Process Instructions (MPI’s), bar code serial number tracking, and a comprehensive quality workbench all support the needs of our medical customers. New programs are regularly being developed to handle challenges of the medical industry.