AccuTec Improves Operational Excellence and Regulatory Compliance with GENEDGE Support

Accutec is a leading manufacturer of precision cutting tools for the medical, industrial, and personal care markets. Located in Verona, Virginia, Accutec employs around 80 people.

AccuTec serves a diverse range of customers with demanding quality and regulatory requirements. As part of its strategic growth plan, AccuTec needed to improve its quality systems to support its expanding medical device business, identify operational efficiencies, cut energy costs, and prepare for future growth opportunities. The company turned to GENEDGE, part of the MEP National Network™, for comprehensive support across several key initiatives.

GENEDGE delivered quality and regulatory consulting that greatly improved AccuTec’s operational efficiency and global market readiness. By guiding the company through complex CE certification processes, MDR compliance, and technical file updates - including supplier validation and product classification - the consulting team ensured compliance while supporting strategic growth. Their expertise helped clarify the regulatory status of existing products, avoiding unnecessary certification barriers, and facilitated the addition of new products under existing CE scopes. Additionally, assistance with GUDID entries, labeling approvals, and SKU management simplified documentation and product traceability, enabling the company to confidently expand internationally and uphold regulatory standards across various markets.