Linamar MedTech Completes ISO 13485 Certification for Medical Device Manufacturing

Linamar, a global diversified manufacturing company, completed its iHub production site and received ISO 13485 certification for medical device production. This is a milestone for the company’s recently created MedTech group, clearing the way for Linamar to become a supplier to the global medical device markets.

The Linamar iHub, located in Guelph, ON, is the first of Linamar’s global facilities to obtain the medical device specific certification from the Internal Standards Organization (ISO). This facility led the initial response to the COVID-19 outbreak, urgently scaling up production efforts to support the manufacture of lifesaving ventilators and critical medical supplies. The facility is also focused on innovation for the future, incubating new technologies and ideas around process and product innovation supporting the company’s rapid evolution into advanced manufacturing.

“We are thrilled to take the next step towards our entry into the medical device market,” Linda Hasenfratz, executive chair and CEO of Linamar, said. “At the onset of the COVID-19 outbreak, we rapidly pivoted our production to ventilator systems, modules and components. The team at the Linamar iHub clearly demonstrated that our manufacturing expertise, quality systems, supply chain management and launch capabilities can be applied to medical device manufacturing. With the ISO 13485 certification process complete, we now have the qualifications to pursue new potential customers within the MedTech space.”

Linamar MedTech is the newest division of Linamar Corporation and is focused on contract manufacturing of complex medical device assemblies as well as precision machined medical components.

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