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. 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.
Founded in 2005, LOK North America is a company headquartered in the Greater Montreal area, in the heart of the life sciences environment.
Our national and international clients turn to us for a full range of services for their medical devices, whether design control development, quality management, risk identification and management, software verification and validation or market approval. We bring together dynamic experts with diversified profiles, who are competent and combine legal and technical knowledge in all relevant sectors. We provide those services to medical device manufacturers wishing to get approval for the US, Canadian and European markets.
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.