AccuTec Enhances Operational Excellence and Regulatory Compliance with GENEDGE Support
AccuTec Inc. of Verona, Virginia. Manufacturer of precision blades for medical, industrial, and personal care markets
Situation:
AccuTec, a leading U.S. manufacturer of precision cutting tools, serves a diverse range of customers with demanding quality and regulatory requirements. As part of its strategic growth plan, AccuTec needed to enhance its quality systems to support its growing medical device business, identify operational efficiencies, reduce energy costs, and prepare for future expansion opportunities. The company turned to GENEDGE, part of the MEP National Network™, for comprehensive support across several key initiatives.
Solution:
GENEDGE provided quality and regulatory consulting that significantly enhanced AccuTec’s operational efficiency and global market readiness. By guiding the company through complex CE certification pathways, MDR readiness, and technical file updates – including supplier validation and product classification – the consulting team ensured compliance while enabling strategic expansion. Their expertise helped clarify the regulatory status of existing products, avoiding unnecessary certification hurdles, and facilitated the inclusion of new products under existing CE scopes. Additionally, support with GUDID entries, labeling approvals, and SKU management streamlined documentation and product traceability, empowering the company to confidently pursue international sales and maintain regulatory integrity across diverse markets.
Results:
As a result of GENEDGE’s engagement, AccuTec achieved measurable business outcomes, including:
- Increased Sales: $200,000
- Retained Sales: $5,400,000
- New Investment in Equipment and Systems: $150,000
- Avoided/Saved Investment Costs: $50,000
- Jobs Created/Retained: 4
“GENEDGE has been an invaluable partner in helping us build the systems and capabilities we need to grow and compete in demanding markets like medical devices. Their expertise and hands-on support helped us accelerate results and strengthen our foundation for the future.”
— Randy Herman, VP Operations and Engineering, AccuTec, Inc.