Regulatory, guidance and standards for gathering medical device clinical evidence
These three interactive course focus on all aspects of clinical evidence. You will examine the latest requirements and guidance available to ensure that you collect the right type of evidence and sufficient evidence for your medical device. You will learn about the clinical evaluation process, clinical investigations and post market clinical follow up studies and data collection. You will also cover specific clinical documents including the clinical investigation plan, clinical investigation report, clinical evaluation plan, clinical evaluation report, clinical development plan, summary of safety and clinical performance as well as post market clinical follow up plans.
We support IVD leaders improve the technical skills and knowledge of their employees, so they are equipped to overcome challenges and meet business objectives. Working together, we design and deliver technical training courses that align with your learning requirements and business goals. For more information about how we can support your team please get in touch.
Could your IVD team benefit from any of the courses listed above? Or maybe a topic which is not highlighted? We would be happy to discuss your objectives and see how we might be able to help.