Global Certificate in Robotic Medical Device Regulations and Compliance
-- ViewingNowThe Global Certificate in Robotic Medical Device Regulations and Compliance is a comprehensive course designed to meet the growing industry demand for professionals with expertise in this field. This course emphasizes the importance of understanding global regulations, compliance requirements, and quality management systems in the development, production, and distribution of robotic medical devices.
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GBP £ 140
GBP £ 202
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โข Global Regulatory Landscape: Overview of international robotic medical device regulations, including FDA, EU MDR, and other major global markets
โข Robotic Medical Device Classification: Understanding and classifying robotic medical devices according to various regulatory frameworks
โข Clinical Evidence and Evaluation: Designing and implementing clinical trials and evaluations to meet regulatory requirements
โข Quality Management Systems (QMS): Implementing and maintaining QMS for robotic medical devices in compliance with global standards
โข Labeling, Instructions for Use (IFU), and Packaging: Ensuring proper labeling, IFU, and packaging to meet regulatory requirements
โข Post-Market Surveillance (PMS): Implementing PMS programs to monitor and address safety and performance issues post-market
โข Risk Management: Applying risk management principles and techniques to robotic medical devices, including ISO 14971
โข Medical Device Reporting (MDR): Understanding and complying with MDR requirements for reporting adverse events and malfunctions
โข Regulatory Inspections and Audits: Preparing for and managing regulatory inspections and audits for robotic medical devices
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