Medical Device
Technological innovation and the advent of digital technology have put the focus on the need to regulate medical devices and combined products in an increasingly appropriate manner. But what does Combination Product mean? How to market Medical Devices? How to ensure patient safety?
PTM organizes specific training in life science to answer these questions and deepen the issues related to the regulation of the Medical Device and Combination Product.
For more information about our training write to academy@ptm-consulting.it.
Courses Available ON DEMAND:
The medical emergency CoVid 19 has induced the European Commission to accept the request to postpone by a year the date of 26 May 2020 when it was expected the entry into force of Regulation 2017/745 commonly known as Medical Device Regulation (MDR). The crisis generated by Coronavirus has in fact increased the demand for some vital medical devices: in order to avoid shortages or delays in their availability due to requests related to the implementation of MDR, the upcoming deadline has been postponed to 26 May 2021.
This course aims to present the new requirements introduced by the MDR including greater safety control and quality of devices during the product life-cycle and the introduction of the figure of the "qualified person" for medical devices.
The course will present how to address the development and registration of a combination fi product in the light of FDA and EMA regulations. Starting from normative aspects and relative impacts on the Quality System in the field of Combination Product, the course aims to offer a comprehensive overview based on a diversified series: pre-Syringes, auto injector, DPI and pMDI inhalers will be the different project scenarios illustrated by PTM through the case histories presented.