This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned. Training Objectives: Gain a general understanding of IEC 60601 standards (collateral and particular...
Cybersecurity
This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned. Training Objectives: This training is intended to allow the participants to understand the requirements...
Substance-based Device Regulation
This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned. Training Objectives: The goal of this training is to provide participants with an introduction to substance-based...
Person Responsible for Regulatory Compliance (PRRC) – EU & Swiss Regulations
This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned. Training Objectives: Understand the regulatory context of PRRC roles and responsibilities in both EU and CH...
Webinar: Leveraging FDA Clearance/Approval for Successful EU MDR Submissions
The transition phase to MDR (Regulation (EU) 2017/745) has been underway since mid-2020 and has introduced new requirements for medical devices. Experience gained with numerous Notified Bodies during this critical time has highlighted common pitfalls and areas where...
Article by Veranex explores the intersections between Machine Learning and Medical Device Regulations
In this article written by our software regulatory team, we explore how machine learning intersects with medical device development and how the regulatory framework has been evolving to keep up with innovation.
Regulatory Affairs and Quality Management Sales Sheet
Training: Artificial Intelligence (AI) In the Medical Device Industry
Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director Date: October 31st 2024, Online Duration: 4 hours | 9:00 AM – 1:00 PM (EDT), 2:00 PM – 6:00 PM (CET) For more information or questions, please contact: training@veranex.com About the...