Domico Med-Device

Success with The Center

DOMICO MED-DEVICE: Pursuing Continuous Improvement Through Internal Audits

The Center not only taught us the required elements of internal audits, but how to conduct an audit professionally within Domico. We now treat audits as an important part of our process improvement strategy throughout our company.
-- Dan Hayes, Quality System Lead

Domico Med-Device (, headquartered in Fenton, Mich., specializes in designing and manufacturing products, accessories and system components for medical device OEMs and distributors. Founded in 1974, Domico split from their previous parent company in 2018 and found great success and strong growth under the leadership of their CEO, Michael Czop. Domico’s in-house capabilities include carbon fiber forming, compression molding, foam fabrication, sewing, contamination resistant sealing, coatings, vacuum forming, product assembly, printing and marking and tool design. Currently, they have 90 employees at their Fenton facility.


To serve the medical device industry, Domico is certified to ISO 13485. In the past, Domico had subcontracted a third party to perform internal audits to ensure compliance to the ISO standard. The decision was made that the internal audits needed to be performed in-house so they could be used as an opportunity to implement improvements to their processes. Dan Hayes, Domico’s Quality System Lead, was tasked with building the plan for performing internal quality audits and a process for corrective actions and review.


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Domico turned to the Michigan Manufacturing Technology Center’s Northeast office (The Center – NE) to train their team on ISO 13485 and to build their internal audit expertise and procedures. The Center – NE was chosen due to their deep knowledge of ISO 13485 and quality system certifications, as well as their expertise in the best methodology for performing internal audits. After completing the Internal Auditor training course, Domico now regularly conducts audits to not only improve operations, but to gain a deeper understanding of the inner workings of the company as a whole.


  • Sales Retained: $10,000,000
  • Jobs Retained: 60
  • New auditors successfully completed the first cycle of audits