Enova Illumination 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.
Vice President of Operations Jeremy Ward had previous experience working with MMTC, Michigan MEP center, part of the MEP National Network™, and knew of the value these centers bring to small and midsize manufacturing operations. When Jeremy contacted Enterprise Minnesota, also part of the MEP National Network™, Enova Illumination had been utilizing an older quality management system (QMS) system based on ISO 13485, but they needed to refresh their internal documentation and processes to be compliant to the current standard and more effective for the way the business was operating today.
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.
Working with Ally was great. She was able to help us focus on the one area that we needed Enterprise Minnesota's resources for. She kept us on a timeline and brought a very large knowledge base to the project, which was greatly appreciated. Ally worked with my team in a way that made them feel comfortable and they learned a lot.
Enterprise Minnesota expert 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 Ally’s continued support to review and improve four of their key processes by focusing on documentation, process flow, and employee training.
Enova was able to leverage Ally’s expertise and knowledge of industry best practices to create an ISO 13485:2016-compliant set of critical business processes that fit their company culture. From this work, Enova Illumination went on to become fully certified, which earned them a key strategic partnership, significantly growing their business and market share.