Clinical Evaluation Report Writing Training
If you are actively involved with the creation and maintenance of clinical evaluation files, our 2 day 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 team performs clinical evaluation reviews for notified bodies, allowing us to give you insights into the common pitfalls.
Unlike many other online trainings, we encourage you to bring and ask as many questions as you like! This is the best way to embed your knowledge and gain a thorough understanding. We are here to help you make your medical devices compliant.
This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials.
▪ Data analysis
▪ Data appraisal
▪ Data identification
▪ Regulation intentions
▪ Clinical investigations
▪ Post-Market Surveillance
You have the opportunity to ask as many questions as you like to our expert trainers throughout the course.
Duration: 2 Days
Day 1: 8:30am - 16:30pm
Day 2: 9:00am - 16:30pm
Due to the nature of the course, an exact time of each topic can not be provided.
The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.
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
▪ The opportunity to get your questions answered!
▪ Full tutor support
Don't just take our word for it - take a look at just a few of our virtual classroom attendee reviews!