MedDev Day

The MedDev Day keeps the discussion going!
Enrol in the online event to take place in 21st – 24th September 2021!
A 4-day event to discuss ongoing hot topics in the world of Medical Devices (MDs), In-Vitro Diagnostics (IVDs) and Software Medical Devices (SaMD).

The regulations are already tough – and getting tougher. The MDR and the IVDR place more emphasis on a life-cycle approach to safety, backed up by clinical performance data. Both regulations present stringent requirements for Notified Bodies, control and monitoring by competent authorities. Within this context, staying up to date with the latest news and discussions in the global medical device industry is a complex task.

The MedDev Day, organized by LS Academy has reached its third edition, and will once again serve as a central meeting place for the medical technology industry, bringing together lecture forums, interviews, workshops and networking opportunities. The event will be 360-degree overview of the evolving context of medical devices, in-vitro-diagnostics and software.
Hot topics in discussion will include:

• Strategic approach to the claims in the clinical evaluation and MDR requirements
• RWD & RWE in clinical evaluations
• Benchmarking clinical data for better study designs
• How to implement Post-Market Surveillance processes following MDR art. 88
• IVDR and technical documentation
• Regulatory management of medical devices under the MDR
• Cybersecurity of medical devices
• Scientific validation of algorithms

«Over the past 10 years, the medical device industry has been growing on average 4.2% per annum in the European medical device market. (…) Medical technology is characterized by a constant flow of innovations, which are the results of a high level of research and development within the industry, and of close cooperation with the users (1).»

Scientific Board
Francesco Dell'Antonio - Head of Quality & Regulatory at Inpeco SA
Laura Michellini -Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Sascha Wettmarshausen - Head of Regulatory Affairs at VDGH e.V. (German IVD-Association)
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Laura C Collada Ali - MedDev Day Scientific Coordinator, LS Academy

Who should attend?
The event is designed for professionals in the field of Medical Devices, devoted to departments such as:

• Clinical Operations
• Product Managers
• Regulatory Affairs
• Quality Assurance/Control
• Risk Management
• Medical Device Engineering
• Device vigilance
• R&D
• Medical Affairs
• Medical Writring

from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations.

(1)MedTech Europe. The European Medical Technology Industry in figures 2020.
Available here: https://www.medtecheurope.org/wp-content/uploads/2020/05/The-European-Medical-Technology-Industry-in-figures-2020.pdf