MDI receives ISO 13485:2016 Certification

Non-profit manufacturing company MDI has received ISO 13845:2016 certification, which will allow the firm to offer assembly, kitting, and packaging services to medical device entities. Headquartered in Minneapolis with additional locations in Hibbing, Minn.; Grand Rapids, Mich.; and Cohasset, Mass.; nearly 50 percent of MDI’s employees are people with disabilities.
 
“We believe we are the only nonprofit in the state that has this certification,” said Peter McDermott, president and CEO of MDI. “This allows us to extend our high-quality labor and services to medical device manufacturers, ultimately providing more jobs for people with disabilities.”
 
As a non-profit organization, MDI’s mission is to serve people with disabilities by offering inclusive employment opportunities and services. With the recent certification and build-out of a 2,000 square foot ‘white room’ space, the organization is looking to attract more opportunities throughout the United States and from the nearly 700 medical device companies that have headquarters or major operations in Minnesota.
 
“Achieving this certification is imperative to building strong, longstanding partnerships with medical device companies,” said Nathan Trout, medical sales account manager at MDI. “We are now uniquely positioned to provide services to a whole new sector of business.”
 
ISO 13845:2016 is a global certification for a quality management system for medical devices and related services that consistently meet customer and applicable regulatory requirements.
 
“High-quality, skilled packaging and assembly options for medical devices are in high demand,” said MDI advisory board member Jim Vogl, who also serves as vice president and general manager of Patient Services & Monitoring at Medtronic plc. “Adding another option that is also a nonprofit with strong values is beneficial for medical device companies and everyone that MDI serves.”
 
MDI is a leader in manufacturing corrugated standard and custom plastic packaging solutions, production assembly, and environmental services. As a non-profit through a social enterprise model, MDI creates self-sufficiency by providing meaningful work in an inclusive environment.