MDR (EU) 2017/745
Conformity assessment and certification under the European Medical Device Regulation for market access.
Learn MoreOrthopedic & Implantable Devices
Comprehensive certification services for orthopedic implants, joint replacements, spinal devices, and bone fixation systems under MDR.
Certification for Orthopedic & Implantable Devices
Orthopedic and implantable medical devices — including joint replacements, spinal fusion systems, bone fixation plates, and surgical meshes — face stringent regulatory scrutiny due to their long-term presence in the human body. The MDR has introduced enhanced requirements for clinical evidence and post-market clinical follow-up for these device categories.
Udem Atlantic's assessment team brings specialized knowledge in materials science, biomechanics, and the clinical performance expectations for orthopedic implants. We help manufacturers navigate the complex requirements for technical documentation, including biocompatibility testing per ISO 10993, mechanical testing standards, and clinical evaluation reports.
Whether you are bringing a novel implant to market or transitioning existing MDD certificates to MDR compliance, our team provides the technical depth and regulatory expertise needed to achieve certification efficiently. Our ISO 13485 auditors understand the specific quality system requirements for implant manufacturing, including process validation, sterilization controls, and traceability systems.