Makrocare
Member
As a Regulatory Authorized Representative for Medical Devices operating under the purview of the U.S. Food and Drug Administration (FDA), we at [Company Name] offer expert assistance to medical device manufacturers seeking market entry and compliance within the United States.
Our role as your Regulatory Authorized Representative involves acting as a liaison between your company and the FDA, ensuring that your devices meet all regulatory requirements for distribution and sale in the U.S. market. We facilitate communication with the FDA on your behalf, aiding in the submission of premarket notifications (510(k)), premarket approval applications (PMA), and other regulatory submissions as required.
With a comprehensive understanding of FDA regulations and industry standards, our experienced team provides strategic guidance to streamline the regulatory process and expedite market approval for your medical devices. We assist in preparing and reviewing regulatory documentation, conducting risk assessments, and addressing any inquiries or requests for additional information from the FDA.
for more info: https://www.makrocare.com/devices/regulatory/local-authorized-representative/
Our role as your Regulatory Authorized Representative involves acting as a liaison between your company and the FDA, ensuring that your devices meet all regulatory requirements for distribution and sale in the U.S. market. We facilitate communication with the FDA on your behalf, aiding in the submission of premarket notifications (510(k)), premarket approval applications (PMA), and other regulatory submissions as required.
With a comprehensive understanding of FDA regulations and industry standards, our experienced team provides strategic guidance to streamline the regulatory process and expedite market approval for your medical devices. We assist in preparing and reviewing regulatory documentation, conducting risk assessments, and addressing any inquiries or requests for additional information from the FDA.
for more info: https://www.makrocare.com/devices/regulatory/local-authorized-representative/
