LOK North America

Canadian regulatory & QMS
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Available to all companies in the final cohort.

LOK QualiT offers a way for many foreign manufacturers to have access to the Canadian market at a lower cost and often more quickly.

Health Canada homologation process requires that all medical devices that are Class II and above have a quality management system that is compliant to ISO 13485:2016 and is MDSAP certified. The MDSAP certification is often a significant hurdle that stops foreign manufacturers form submitting their applications to Health Canada. The costs and delays to get audited are often the problem. Through LOK QualiT, we’ve built a legal solution that, for a number of manufacturers, allows them to get to sell their products more quickly and offers cost savings. The cost of use of the system we charge varies between $15,000 and $19,000 per product per year. The first year of this service is available at no charge for Rosenman Innovators.

LOK North America