Clinical Data Evaluation for Medical Devices
If you are actively involved with the creation and maintenance of clinical evaluation files, our two day real-time instructor-led 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.
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.
Our virtual courses allow you to join our expert tutors and fellow delegates together on a web based classroom where you can fully engage in group activities, ask questions and share materials as if you were in a real classroom. All you need to be able to attend is access to a microphone and Google Chrome.
▪ Data analysis
▪ Data appraisal
▪ Data identification
▪ Regulation intentions
▪ Clinical investigations
▪ Post-Market Surveillance
Who should attend?
This Clinical Evaluation training course has great value for anyone involved in implementing or maintain a clinical evaluation file.
▪ Quality Assurance professionals
▪ Quality Engineers
▪ Research and Design Engineers
▪ Internal Auditors
▪ Quality Managers
▪ Manufacturing Engineers
▪ Regulatory professionals
What will I receive?
▪ PDF training course notes, slides and handouts
▪ PDF Clinical Evaluation training course certificate
▪ Full tutor support and access during course times
Our software will allow you to:
▪ Raise your 'virtual' hand to ask questions
▪ Participate in polls and surveys and see results
▪ Undertake exercises on your own or in a group
▪ Download and share materials and documents
▪ Chat online with the facilitators and other delegates