CIMTI training session: How does the regulation of medical devices affect your innovative solution?

Medical devices are regulated and in order to be commercialized in Europe, they must obtain the CE conformity marking in accordance with the MDR and IVDR regulations, as well as comply with the royal decrees that establish additional requirements in Spain. In this training, we have analyzed the current situation along with the latest developments and updates related to the fundamentals of CE marking:

• Strategy for obtaining CE marking.
• The need for Clinical Research.
• Technical documentation of products according to Annexes II and III.
• Quality Management System according to regulations and ISO 13485.
• Registration of products and organizations in the CR – AEMPS and EUDAMED.

Our goal is that any innovative project can incorporate regulatory requirements from the beginning to achieve success.

The training has benn divided into two parts:

Live webinar: November 9, 2023, from 9:00 a.m. to 2:00 p.m. with a break from 11:00 a.m. to 11:20 a.m.
E-learning: 25 additional hours over 3 months (optional but necessary to obtain the training certificate).