The Crash Course in EU Medical Device Law for Pharma Professionals 2015 covers topics such as:
- Explain the responsibilities of EMA, competent authorities and notified bodies
- Understand differences between pharma and medical device law
- Clinical data and evaluation according to MEDDEV 2.7.1
- Classification of medical devices and impact on data requirements
- Device & drug combination products
- Conformity assessment and CE-marking of medical devices
- Revision of EU medical device law
- Risk management and vigilance
The Crash Course in EU Medical Device Law for Pharma Professionals 2015 brings together senior attendees involved or interested in Experienced professionals and newcomers in pharma and medtech industries.
