Clinical Evaluation Training
If you are actively involved with the creation and maintenance of clinical evaluation files, our expert tutors have created a 2-day course to enhance your level of understanding on the application of key methods to ensure that the requirements of the new Medical Device Regulation are met.
We give you the necessary skills to ensure all the requirements of the law are met and 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.
By the end of this practical and interactive course, delegates are able to understand the theory of planning, conducting and producing a clinical evaluation report which will meet the requirements of the law.
Learning objectives include:
▪ Practical use of MEDDEV 2.7.1 rev4
▪ The limits of MEDDEV 2.7.1 rev4
▪ The additional requirements for clinical evaluation imposed by the Medical Device Regulation
▪ Methods of real-world literature review
▪ Techniques for establishing that sufficient information is presented in a clinical evaluation report
▪ Post-market requirements
▪ How to address continuous updates of a clinical
evaluation report in a practical way
▪ Conducting post-market clinical follow-up
▪ Where clinical evaluation fits in the legal framework
Who should attend?
The content will have great value to individuals who are involved in any aspect of implementing or maintaining a clinical evaluation.
▪ Quality assurance professionals
▪ Quality Engineers
▪ Research and design Engineers
▪ Internal Auditors
▪ Quality Managers
▪ Manufacturing Engineers
▪ Regulatory professionals
What will I receive?
▪ Detailed course notes
▪ A Meddev Solutions Training course certificate
▪ Lunch and refreshments provided both days
How much is the course?
This course is £575 per person. This price is inclusive of VAT.
Travel and accommodation is not included in the course price. If required, our team are on hand to help you make your travel arrangements and offer
Prefer online training? We offer that too!
This online course will offer an interactive overview of Clinical Data Evaluation
for Medical Devices & MEDDEV 2.7/1.
Duration: 7 hours
Release Date: Coming Soon
We have partnered with Comply Guru to bring you a growing library of Online Medical Device Regulatory Affairs Courses!
Comply Guru offers industry-leading online and blended training solutions to enable learners to get the knowledge and skills they need, from the same systems and devices they use every day!
Each one of our courses has been created by our expert team of consultants to ensure that all of our courses deliver you the right knowledge in a meaningful way that will meet your needs.
Take a look at our Clinical online course offerings below!