16-hour Clinical Data Evaluation Foundation Course
In 2016, MEDDEV 2.7/1 rev 4 was published. This bought more stringent requirements for complying with clinical data evaluation to comply with medical device regulations. These requirements were not well understood by industry, and with the looming Medical Device Regulation, it has never been more imperative that you get clinical data right.
We have performed 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.
This course is fully certified by Comply Guru™ & Meddev Solutions.
In order to successfully complete the course, you will need to obtain a grade of 70% or higher in the final multiple choice examination. Successful completion will entitle you to receive a certificate of completion.
Who should attend?
▪ Quality assurance professionals
▪ Quality Engineers
▪ Research and design Engineers
▪ Internal Auditors
▪ Quality Managers
▪ Manufacturing Engineers
▪ Regulatory professionals