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An EU manufacturer of a novel wound management device planned to enter the Canadian market but needed support understanding and complying with Health Canada requirements. PASB was hired to identify and remediate gaps in their QMS to meet MDSAP requirements for Canada, the USA, Brazil, Australia, and Japan. We also assisted with the submission of their Medical Device Licence Application to Health Canada, performed Canadian market analysis, and identified key opinion leaders in the Canadian wound care space to champion the product.