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You’ll gain an in-depth overview of the Medical Device Regulation (MDR) clinical requirements as they apply to spinal implants.
Gain a clear and practical understanding of the clinical requirements under the Medical Device Regulation (MDR) for spinal implants.
The impact of the EU MDR on spinal devices and associated clinical requirements.
Clinical safety and performance objectives under MDR.
Acceptable sources of clinical data, including PMCF studies, registries and scientific literature.
Common issues identified during submissions and conformity assessments by notified bodies.
Principal Technical Specialist & Scheme Manager, BSI
Technical Team Manager, Orthopaedic & Dental, BSI
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