Case Study: Northeast Scientific achieves faster regulatory approvals and scalable, compliant manufacturing with MasterControl

How Digitizing Operations Keeps Northeast Scientific a Leader in the Medical Device Industry

Northeast Scientific, a Waterbury, CT–based remanufacturer founded in 2005, is a market leader in high-end peripheral vascular catheter remanufacturing that serves physicians in office-based labs. As its product portfolio and regulatory demands grew, the company was constrained by paper-based processes that caused slow reporting, damaged or lost documents, training gaps, and difficulty scaling new-product submissions and regulatory clearances.

To solve this, Northeast Scientific implemented MasterControl’s Quality Excellence (Qx) and Manufacturing Excellence (Mx) to digitize document control, training, equipment maintenance, and lot tracking. The change cut SOP, validation, and training cycle times to roughly a third or quarter of what they were, enabled the company to pursue four to five 510(k)s at once (up from one per year), eliminated lost/damaged records, improved scheduling and forecasting, and sped products to market.

Northeast Scientific

Craig Allmendinger

Chief Executive Officer and President