MDR (EU) 2017/745
Conformity assessment and certification under the European Medical Device Regulation for market access.
Learn MoreCardiovascular Devices
MDR certification and ISO 13485 compliance services for cardiovascular medical device manufacturers including pacemakers, stents, and heart valves.
Certification for Cardiovascular Medical Devices
Cardiovascular devices represent one of the most critical and highly regulated segments of the medical device industry. From pacemakers and defibrillators to coronary stents and heart valves, these life-sustaining technologies require rigorous conformity assessment to ensure patient safety and efficacy.
At Udem Atlantic, our assessment team includes specialists with extensive experience in evaluating cardiovascular devices under MDR (EU) 2017/745. We understand the unique clinical evaluation challenges, biocompatibility requirements, and long-term performance data needed for Class III and Class IIb cardiovascular devices.
Our services for cardiovascular device manufacturers include comprehensive technical documentation review, quality management system audits under ISO 13485, and conformity assessment for CE marking. We work closely with manufacturers to address the specific regulatory requirements for active implantable devices and high-risk cardiovascular technologies.