Regulering af medicinsk udstyr



The purpose of this course is to give an understanding of the regulatory considerations involved in the development and implementation of a medical device.
Medical device development is a time- and money consuming task, due to the high safety and regulations. Developers ignorance of the complex regulatory system offend postpones the release of the product.
This course will give an overview of the regulation within medical devices, including CE-markings and ISO-standards.
Periode01/02/2019 → …
ECTS-point5,0 ECTS