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 QMS principles and the links between the different QMS processes Define...
Overview of the PMS and PMCF requirements under the Medical Device Regulation (MDR)
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 Post Market Surveillance (PMS) & Post Market Clinical Follow-up (PMCF)...
Electrical Safety
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.