Illuminating Possibilities to Achieve ISO Certification

Enova Illumination, a client of Enterprise Minnesota (Minnesota MEP), is a leading provider of LED surgical headlights, magnification systems, and other visualization solutions for healthcare professionals. The company was founded in 2006 to address the limitations of traditional fiber-optic surgical headlights. Enova employs 50 people and operates from a single location in Minneapolis, Minnesota.

When Enova Illumination Vice President of Operations Jeremy Ward contacted Enterprise Minnesota, part of the MEP National Network™, the company had been using an older quality management system (QMS) based on ISO 13485. It needed to refresh its internal documentation and processes to be compliant to the current standard and more effective for the way the business was operating today.

MEP Center brings industry expertise

Based on the growth and workload the business was experiencing, the leadership team understood that the company lacked the resources to manage the project internally. They wanted the support of an outside partner that could bring industry expertise and best practices to help them update their QMS in the most timely and effective manner possible.

Enterprise Minnesota consultant Ally Johnston was brought in to conduct a lean assessment of the organization and create a roadmap of opportunities for improvement as Enova Illumination sought to become ISO 13485:2016 compliant, with a future goal of gaining this valuable medical device certification.

Based on the assessment recommendations, Enova’s leadership team retained Johnston’s continued support to review and improve key processes by focusing on documentation, process flow, and employee training.

Enova was able to leverage Johnston’s expertise and knowledge of industry best practices to create an ISO 13485:2016-compliant set of critical business processes that fit its company culture. From this work, Enova Illumination went on to become fully certified, which earned it a key strategic partnership, significantly growing its business and market share.

Results

• $3,000,000 in new or retained sales
• 15 created or retained jobs
• $250,000 in new investment

Success stories from the MEP National Network

The MEP National Network^TM has more than 1,200 success stories representing its work with U.S. manufacturers. Find out how MEP Centers in your area have helped thousands of manufacturers improve operations, increase profits, create or maintain jobs, and establish a foundation for long-term business growth and productivity. Centers tailor services to meet critical needs, ranging from process improvement and workforce development to specialized business practices, including supply chain integration, innovation, and technology transfer.

Could your company benefit from assistance with an ISO certification? Connect with your local MEP Center for more information.

Enterprise Minnesota is the official representative of the MEP National Network in Minnesota. The MEP National Network is a unique public-private partnership that helps small and medium-sized manufacturers generate business results and thrive in today’s technology-driven economy. The MEP National Network comprises the National Institute of Standards and Technology’s Manufacturing Extension Partnership (NIST MEP), the 51 MEP Centers located in all 50 states and Puerto Rico, the MEP Advisory Board, MEP Center boards, and the Foundation for Manufacturing Excellence, as well as more than 1,450 trusted advisors and experts at approximately 430 MEP service locations, providing any U.S. manufacturer with access to resources it needs to succeed.