THE CHALLENGE Missed timelines and EDC build errors compromised the potential success of the company’s phase 1 study.THE SOLUTION Experienced team members and robust internal reviews resulted in a timely, high-quality EDC build and data management plan.THE OUTCOME...
Webinar: 2024 IVDR Sprint – How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines
2024 IVDR Sprint How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines The In-Vitro Diagnostic (IVD) industry plays a pivotal role in modern healthcare by providing crucial information for patient management. In Europe, the...
Webinar: Introduction to ISO/IEC 27001 – Information Security Management Systems
Introduction to ISO/IEC 27001 - Information Security Management Systems A key component to protect your data Information security is a critical field dedicated to safeguarding an organization's digital assets, data, and information systems from unauthorized...
Webinar: Regulatory Strategy for New Neurological Medical Devices
Regulatory Strategy for New Neurological Medical Devices Considerations for an effective balance between non-clinical and pre-clinical evaluations Regulatory considerations and preclinical aspects are major parts of getting any medical device to market. Finding...
Webinar: Medical Devices Incorporating or Generating Nanomaterials
Medical Devices Incorporating or Generating Nanomaterials What manufacturers should consider to ensure safety and biocompatibility The concept of nanomaterials and their possible applications was first introduced by Richard Feynman, which earned him the...
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...