Linamar MedTech Achieves ISO 13485 Certification for Medical Device Manufacturing


GUELPH, ON, Aug. 24, 2022 /PRNewswire/ – Linamar Corporation (TSX: LNR), a leading global diversified manufacturing company, announced today its iHub production site has received ISO 13485 certification for medical device production. 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-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,” said 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, for better products at a better price.   

For more information on Linamar MedTech product or services, please visit our website at https://www.linamar.com/medtech/ or email us at MedTech@Linamar.com

Forward Looking Information, Risk and Uncertainties

Certain information regarding Linamar set forth in this document and oral summary, including management’s assessment of the Company’s future plans and operations may constitute forward looking statements. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict. Actual results may differ materially from these anticipated in the forward-looking statements due to factors such as customer demand and timing of buying decisions, product mix, competitive products and pricing pressure. In addition, uncertainties and difficulties in domestic and foreign financial markets and economies could adversely affect demand from customers. These factors, as well as general economic and political conditions and public health threats, may in turn have a material adverse effect on the Company’s financial results. Please also refer to Linamar’s most current Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) and Annual Information Form (“AIF”), as replaced or updated by any of Linamar’s subsequent regulatory filings, which set out the cautionary disclaimers, including the risk factors that could cause actual events to differ materially from these indicated by such forward looking statements. These documents are available at www.linamar.com/investors

. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements. Content is protected by copyright and may not be reproduced or repurposed without express written consent by the Company.

Linamar Corporation (TSX:LNR) is an advanced manufacturing company where the intersection of leading-edge technology and deep manufacturing expertise is creating solutions that power vehicles, motion, work and lives for the future. The Company is made up of two operating segments – the Industrial segment and the Mobility segment, both global leaders in manufacturing solutions and world-class developers of highly engineered products. The Industrial segment is comprised of Skyjack, MacDon and Salford. Skyjack manufactures scissors, booms and telehandler lifts for the aerial work platform industry. MacDon manufactures combine draper headers and self-propelled windrowers for the agricultural harvesting industry. Salford also supplies the agriculture market with farm tillage and crop nutrition application equipment. The Mobility segment is subdivided into three regional groups: North America, Europe and Asia Pacific. Within the Mobility segment, the regional groups are vertically integrated operations combining expertise in light metal casting, forging, machining and assembly for both the global electrified and traditionally powered vehicle markets. The Mobility segment products are focused on both components and systems for new energy powertrains, body and chassis, driveline, engine and transmission systems of these vehicles. In addition to the recently formed eLIN Product Solutions Group that focuses on Electrification, McLaren Engineering provides design, development, and testing services for the Mobility segment. Linamar has 26,796 employees in 65 manufacturing locations, 14 R&D centres and 28 sales offices in 17 countries in North and South America, Europe and Asia, which generated sales of more than $6.5 billion in 2021. For more information about Linamar Corporation and its industry-leading products and services, visit www.linamar.com or follow us on our social media channels.

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