Linamar MedTech earns ISO 13485 certification for medical device manufacturing
by CM Staff
The Linamar iHub, located in Guelph, Ont. is the first of Linamar's global facilities to obtain the medical device specific certification from the Internal Standards Organization.
GUELPH — Linamar Corporation says its iHub production site has received ISO 13485 certification for medical device production.
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, Ont. is the first of Linamar’s global facilities to obtain the medical device specific certification from the Internal Standards Organization.
This facility became involved in the initial response to the COVID-19 outbreak, scaling up production efforts to support the manufacture of ventilators and critical medical supplies. The facility is also focused on incubating new technologies and ideas around process.
“We are thrilled to take the next step towards our entry into the Medical Device market,” said Linda Hasenfratz, Linamar executive chair and CEO in a statement.
“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 focuses on contract manufacturing of medical device assemblies as well as precision machined medical components.
