Clinical Evaluation Report Training
Clinical Evaluation for Medical Devices
Category: Clinical Training, Clinical Evaluation Report Training, Medical Device Clinical Evaluation
If you are actively involved with the creation and maintenance of clinical evaluation files, our two day clinical evaluation report training course will enhance your level of understanding on the application of key methods to ensure that the requirements of the new MDR are met.
In 2016, MEDDEV 2.7/1 rev 4 was published, bringing more stringent requirements for complying with clinical data evaluation. These requirements were not well understood by the industry and with the looming Medical Device Regulation (MDR), it has never been more imperative that you get clinical data right.
We perform clinical data evaluation reviews for notified bodies and can offer you insights into common pitfalls. Plus you will get an understanding of what the requirements are really asking for.
Our expert tutors will give you the necessary skills to ensure all the requirements of the law are met and provide an insight into how the clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system.
▪ Data analysis
▪ Data appraisal
▪ Data identification
▪ Regulation intentions
▪ Clinical investigations
▪ Post-Market Surveillance
Who should attend?
This two day training course has great value for anyone involved in
implementing or maintaining clinical evaluation file.
▪ Internal Auditors
▪ Quality Engineers
▪ Quality Managers
▪ Regulatory professionals
▪ Manufacturing Engineers
▪ Research and Design Engineers
▪ Quality Assurance professionals
What will I receive?
▪ Training course notes
▪ Clinical evaluation report training course certificate