SUCCESS STORY

EnTech started serving customers in the medical device sector, producing specialized cases and components. To expand its footprint in this highly regulated market, the company needed to upgrade its Quality Management System (QMS) and achieve ISO 13485 certification—a critical requirement for doing business in the medical device industry. Certification would unlock new business opportunities, improve internal processes, and demonstrate regulatory compliance. However, limited internal resources and competing priorities made it difficult to manage the implementation alone.

EnTech Plastics partnered with NWIRC and Core Business Solutions to implement
ISO 13485 through a structured, hands-on consulting program. The approach emphasized simplicity, business value, and practical integration of ISO requirements. Over the course of the project, EnTech received support in gap analysis, documentation development, internal audits, and management review facilitation. The project also included one-on-one coaching for process owners and a certification promotional package to help communicate the achievement to customers. This initiative was supported in-part by the Mid-Atlantic Trade Adjustment Assistance Center (MATAAC), a program to offset implementation costs and enabled EnTech to invest in quality improvements that will strengthen its competitiveness in global markets.