Global Certificate in MDR Implementation
-- ViewingNowThe Global Certificate in MDR Implementation course is a comprehensive program designed to address the growing demand for professionals skilled in the European Union Medical Device Regulation (MDR). This course highlights the importance of understanding and implementing MDR, which impacts medical device manufacturers, distributors, and notified bodies globally.
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โข MDR Overview: Understanding the Medical Device Regulation, its scope, and the impact on the medical device industry.
โข Classification of Medical Devices: Defining and categorizing medical devices according to the MDR regulations.
โข Technical Documentation: Preparing and maintaining technical documentation in compliance with MDR requirements.
โข Clinical Evaluation: Conducting clinical evaluations and assessments for medical devices under MDR.
โข Post-Market Surveillance: Implementing and managing post-market surveillance systems for medical devices.
โข Vigilance and Reporting: Understanding vigilance systems and reporting requirements under MDR.
โข Quality Management System: Establishing and maintaining a quality management system for medical devices in line with MDR.
โข Notified Bodies and Conformity Assessment: Working with Notified Bodies, understanding the role and selecting the right Notified Body for MDR assessment and certification.
โข Implementation Strategies: Developing strategies for implementing MDR in an organization.
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