The achievement is a critical milestone for the company’s recently announced MedTech group, clearing the way to Linamar becoming a leading supplier to the global medical device markets.
ISO 13485:2016 is an internationally recognized standard of quality and safety for the medical device industry. The management system standard ensures that an organization meets the regulatory requirements specific to the design, manufacture, assembly, and distribution of medical devices.
The Linamar iHub, located in Guelph, Ontario, Canada, 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 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,” says Linda Hasenfratz, Linamar executive \chair and CEO. “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. MedTech is one of the targeted markets outlined in the company’s 2100 Vision for future long-term growth and diversification. Linamar’s capabilities in manufacturing, supply chain, and program management can be leveraged to offer medical equipment OEMs advanced contract manufacturing solutions.