9464-6098 Quebec Inc.

We believe in a healthcare system where every truly useful innovation finds its place in service to patients, caregivers, and institutions. Our goal is to create concrete bridges between manufacturers of innovative medical devices and target markets, facilitating their regulatory compliance and operational integration. The company currently operates as a consulting firm specializing in regulatory, clinical, and quality affairs for medical device manufacturers.

The company assists its clients in preparing, submitting, and monitoring registration dossiers with Health Canada, the FDA, and other international authorities. These services cover compliance review, all research and development review activities, clinical affairs, and quality assurance, to ensure that regulatory requirements are addressed in accordance with the expectations of regulatory agencies during the review and approval processes. It also offers comprehensive support to Quebec and Canadian companies wishing to export their medical devices to foreign markets.