Vermont Manufacturing Extension Center
ASMC Member Providing hands-On Help through the Vermont Manufacturing Extension Center
Cutting Edge Instruments (CEI), founded in 2002, manufactures carbide dental burs used by dentists. The company is located in Bridgewater Corners, Vermont, and employs 17 people.
CEI recognized that achieving ISO 13485:2003 certification would allow them to expand their sales and marketing efforts in Europe and Canada and increase U.S. military and government sales. ISO 13485:2003 is a requirement for applying for the Canadian CMDCAS and the European CE mark certifications. CEI engaged the Vermont Manufacturing Extension Center (VMEC), a NIST MEP network affiliate, in October of 2004 to assist them in preparing for these certifications.
VMEC is a part of the New England Manufacturing Supply Chain Consortium (NEMSC), a partnership that seeks to align manufacturing system capabilities to opportunities to pursue defense supply chain solicitations. NEMSC supported the project from the outset. The first step was to perform a gap analysis of the existing ISO 9002-compliant quality system. VMEC tapped the vast expertise of Joseph Azary of Azary Technologies LLC. Azary Technologies specializes in helping companies prepare their quality systems to meet the requirements of medical device and FDA certification. Mr. Azary used the results of a gap analysis to work with VMEC and CEI personnel to incorporate the more stringent requirements of ISO 13485:2003 into their quality system. CEI also brought in Edgar Bothe, a quality consultant, to help supplement their available internal resources. The combined effort allowed the company to modify their system in just over two months. This included review of all documentation, modifying procedures where necessary, training personnel, and verifying compliance to the new system so that “living the system” continues to yield the largest business benefit possible to the company.
- Achieved ISO 13485:2003 certification in January 2005.
- Applied for CMDCAS and CE mark certification.
- Projected new sales of $1 million.
- Reduced work in process for cost savings of $4,000.
- Improved design procedures for cost savings of $4,000.
- Invested $18,200 in software and workforce practices.
- Produced direct labor cost savings of $33,000.
- Created two new positions in production areas.