Our Medical Device Certification Services
Udem Atlantic is providing comprehensive conformity assessment services for medical device manufacturers seeking access to the European Union market. Our experienced auditors and technical reviewers deliver reliable, transparent, and timely certification services to help manufacturers demonstrate regulatory compliance.
Whether you are a US-based manufacturer looking to enter the EU market or an established company navigating the transition to the new Medical Device Regulation (MDR), Udem Atlantic offers the expertise and authority to assess your products and quality management systems against the applicable regulatory requirements.
MDR (EU) 2017/745 — Medical Device Regulation
The EU Medical Device Regulation (MDR) 2017/745 establishes a robust regulatory framework for medical devices placed on the European market. Conformity assessments under MDR are carried out by a notified body to verify that medical devices meet the essential safety and performance requirements defined by the regulation.
Learn More About MDR CertificationISO 13485 — Quality Management System Certification
ISO 13485:2016 is the internationally recognized standard for quality management systems specific to the medical device industry. Udem Atlantic provides ISO 13485 certification audits that evaluate whether your quality management system meets the requirements for the design, development, production, installation, and servicing of medical devices.
Learn More About ISO 13485 Certification