Cardiovascular Devices
MDR certification and ISO 13485 compliance services for cardiovascular medical device manufacturers including pacemakers, stents, and heart valves.
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Udem Atlantic provides specialized medical device certification services across a wide range of therapeutic areas and device categories.
Every medical device category has unique regulatory considerations, from clinical evaluation requirements to risk classification nuances. Our assessment teams bring specialized experience in each of the following industries, ensuring that your certification process is handled by experts who understand your specific technology and market.
Orthopedic & Implantable Devices
Comprehensive certification services for orthopedic implants, joint replacements, spinal devices, and bone fixation systems under MDR.
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CE marking and MDR certification for diagnostic imaging equipment, patient monitoring systems, and clinical diagnostic devices.
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Regulatory compliance and certification services for reusable and single-use surgical instruments under MDR (EU) 2017/745.
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