MDR (EU) 2017/745 Certification
Comprehensive conformity assessment and certification under the European Medical Device Regulation.
Learn MoreMedical Device Certification Services for US Manufacturers
Expert MDR and ISO 13485 certification — your pathway to global market access.
Our Certification Services
We provide comprehensive certification services to help medical device manufacturers access the European market with confidence.
Your Trusted Certification Partner
Udem Atlantic is a US-based contact office offering expertise in conformity assessment to American medical device manufacturers seeking access to the EU market.
Our mission is to simplify the certification process while maintaining the highest standards of independence and impartiality. We understand the unique challenges US manufacturers face when navigating EU regulations, and we provide dedicated support throughout every step of the certification journey.
About Us
Why Choose Udem Atlantic
Independent & Impartial
Our assessment processes are conducted with complete independence and impartiality, ensuring unbiased evaluations that meet the highest regulatory standards. We maintain strict separation between consultancy and certification activities.
US-Based Support
With our office in Medford, Massachusetts, we offer local support for American manufacturers. Our team understands the specific needs and regulatory landscape for US companies entering the European medical device market.
Global Recognition
We're opening doors to markets across the European Economic Area and beyond. We ensure your device demonstrates compliance with the most rigorous regulatory standards.
Expert Team
Our team comprises experienced auditors, technical experts, and regulatory specialists with extensive backgrounds in medical device assessment. We bring deep knowledge across all device classifications and therapeutic areas.