About Udem Atlantic

Dedicated to helping medical device manufacturers achieve regulatory compliance and market access.

Who We Are

UDEM Atlantic is a U.S.-based contact office of the UDEM A.Ş., headquartered in Medford, Massachusetts. As part of the UDEM A.Ş.’s global conformity assessment structure, UDEM Atlantic is involved in certification and conformity assessment processes for the European market carried out under EU Notified Body designation.

Our presence in the United States is designed to support manufacturers in navigating the Medical Device Regulation (EU) 2017/745 by providing local coordination, communication, and process support throughout the conformity assessment activities.

Independence and impartiality are fundamental principles of the UDEM Atlantic. All conformity assessment activities are performed in accordance with applicable regulatory requirements, ensuring objectivity and the absence of conflicts of interest.

Our Mission & Vision

Our Mission: To support US medical device manufacturers in accessing global markets by facilitating certification and conformity assessment processes carried out under EU regulatory requirements. We are committed to protecting public health by contributing to the availability of safe and effective medical devices bearing the CE mark.

Our Vision: To be a recognized and trusted organization for medical device manufacturers seeking access to international markets, contributing to a regulatory environment where innovative technologies can reach patients in compliance with applicable requirements.

We believe that clear and transparent regulatory processes are essential for both innovation and patient safety. Our team works closely with manufacturers by ensuring clear communication, timely feedback within the conformity assessment process, and consistent interpretation of applicable standards, including ISO 13485 and the Medical Device Regulation (EU) 2017/745.

Our Values

Integrity

We uphold the highest ethical standards in every assessment. Our commitment to honesty and transparency builds trust with manufacturers, regulators, and the public. We never compromise on the integrity of our certifications, because patient safety depends on it.

Excellence

We pursue excellence in every aspect of our work, from technical documentation review to quality management system audits. Our auditors undergo continuous professional development to remain at the forefront of medical device regulation and assessment methodologies.

Independence

Our independence is non-negotiable. We maintain strict organizational and operational separation from any consultancy activities. This independence guarantees that our conformity assessments are objective, credible, and accepted by regulatory authorities across the European Economic Area.

Innovation

We embrace technology and continuous improvement to deliver a certification experience that is efficient and responsive. Our digital-first approach to documentation management and audit scheduling ensures a streamlined process for every client we serve.