What are some of the challenges with database builds for medical device studies, given the current regulatory requirements? What are the important items to be aware of? In this post, we will look at these and other questions, with a focus on data management and...
EN ISO 13485:2016 – Quality Management System (QMS)
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...
EUDAMED
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 EUDAMED and its functional specifications Interpret EUDAMED data...
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: Precision Medicine and Alzheimer’s Disease: Overcoming Biomarker Testing Barriers for Alzheimer’s Disease Patients
Tuesday, October 03, 2023 | 12pm EDT / 11am CDT / 9am PDT / 5pm BST (UK) / 6pm CEST (EU-Central) Advances in biomarker testing are revolutionizing strategies for diagnosing and managing neurological disorders and shifting the current treatment paradigm to a more...
Automation and the Future of Clinical Data Management
Automation in clinical data management (CDM) is becoming increasingly popular due to the increasing volume and complexity of data being generated by clinical trials, as well as the need to improve the efficiency and accuracy of CDM processes. Check out the infographic...