CANCELED

When:
Friday, May 08, 2020 8:30a -
5:00p

Where:
Harvard Law School Wasserstein Hall, Milstein East (2036)
1585 Mass Ave.
Cambridge, MA 02138

EventCancelled OfflineEventAttendanceMode

Admission:
FREE

Categories:
Tech, University

Event website:
https://petrieflom.law.harvard.edu/events/details/2020-petrie-flom-center-annual-conference

Medical devices have historically been less regulated than their drug and biologic counterparts, both before and after coming to market. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety issues.

Furthermore, there is increased awareness that the nature of medical devices is rapidly changing as the market shifts from hardware-only devices to increasing numbers of hybrids of hardware and software, or even software as a medical device (SaMD).

New regulations in the EU and the experiences of the FDA in the United States suggest that medical device regulation overall faces some global challenges, including the correct balance between patient protection and avoiding stifling business and innovation, the changing nature of medical devices to become increasingly software-based, and the difficulties of post-market surveillance. This conference will explore how these concerns can be expressed and successfully addressed in a variety of countries, each with a different medical device market.

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08/05/2020 08:30:00 08/05/2020 17:00:00 15 2020 Petrie-Flom Center Annual Conference: Innovation and Protection: The Future of Medical Device Regulation Medical devices have historically been less regulated than their drug and biologic counterparts, both before and after coming to market. A benefit of this less demanding regulatory regime is facili... Harvard Law School Wasserstein Hall, Milstein East (2036), Cambridge, MA 02138 Organizer Organizer e-mail false DD/MM/YYYY Reddit