Are you working with medical devices and planning to start clinical investigations at some point? We have some good news for you – Medfiles’ new On-line training, tailored especially for your needs. Our regulatory and clinical teams have compiled a training according to Medical device regulation (MDR) 2017/745 that can help you in decision making and conducting the study.
Have you been asking yourself questions such as:
- Do I need to conduct clinical study for my medical device? How is it conducted?
- What information study plan and report must contain?
- Do I need to submit the study to ethics committee?
- Which ISO standards do I need to take into consideration?
- What are my responsibilities as a sponsor?
- What about safety evaluation and reporting?
- What other processes are conducted or updated together with clinical investigation?
Our training answers all these questions and many more. Also note, Medfiles’ On-line training is not time-bound, it can be watched anytime you want.
Did you get interested?
If so, then feel free to contact us and know more about the training packages we offer.
Let our expert help you!