Health Canada Licenses
Health Canada Licenses
Health Canada Licenses
With extensive expertise, we specialize in creating and renewing Medical Device License Applications for Health Canada. Our skilled team meticulously navigates the complexities of Canadian regulatory requirements, ensuring your devices achieve and maintain compliance.
CE Approval (MDR)
Health Canada Licenses
Health Canada Licenses
Our consultancy specializes in crafting MDR-compliant technical files from the ground up, ensuring full compliance with European Union Medical Device Regulation standards. Trust us to expertly navigate the complexities, empowering your medical devices to enter the European market with confidence and success.
FDA Submissions
Health Canada Licenses
FDA Submissions
Dexter Advisors consultancy specializes in preparing 510(k) and PMA submissions for the US FDA. Our expert team meticulously handles every detail and navigates the complex FDA regulatory pathways. Trust us to ensure your medical devices achieve successful market entry in the United States.
ROW
Health Canada Licenses
FDA Submissions
Unlock the power of our unparalleled worldwide regulatory expertise while harnessing local insights on a global scale. With our profound knowledge of national regulations and their intricate connections, we are dedicated to meticulously crafting your global strategy, guiding you from inception to achieving seamless market access across the globe