Does Size Matter? Rescue from a large CRO
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...
Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss important deadlines, exceptions and the main differences in the way these tests will be overseen on these two continents.Please...
Webinar – 2024 IVDR Sprint Series: 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: Panel Discussion – FDA’s Regulation on LDTs: Current Impact and Future
In this recorded panel discussion, members of different healthcare organizations discuss the potential impact of the FDA Rule on LDTs, near term / long term implications, and stakeholder’s priorities for minimal disruption. By watching this panel discussion, you will:...
Webinar – 2024 IVDR Sprint Series: Companion Diagnostics (CDx) – Critical Areas and Implications for Successful Development and Launch in the EU
In this recorded webinar, Amit Kumar Jain and Veronique Treil from Veranex share some of our first-hand industry expertise, helping you stay attuned to the latest industry developments, challenges and advancements specifically related to Companion Diagnostics and...
Webinar – 2024 IVDR Sprint Series: Usability and Human Factors: Cornerstones of Near Patient Testing – Insights and Perspectives from a Notified Body
Near-patient testing (NPT) devices face substantial challenges under the new IVDR, including: New Stringent Regulatory Constraints due to IVDR Risk-Based Approach for Usability and Human Factors, including Use Environment Expectations from Notified Bodies In this...
Webinar – 2024 IVDR Sprint Series: How to Deal with Regulatory Requirements when Collecting Clinical Performance Data
Mastering Time and Compliance How to Deal with Regulatory Requirements when Collecting Clinical Performance Data IVDR imposes stricter requirements for clinical evidence, including a higher level of scrutiny and more stringent criteria for study design,...
Webinar – 2024 IVDR Sprint Series: The Clinical Challenge – Addressing Increased Evidence Requirements in the EU IVDR Era
The Clinical Challenge Addressing Increased Evidence Requirements in the EU IVDR Era In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of...
Webinar: The Impact of the Cleaning Process on Sterilization Validation and Biocompatibility Activities
The Impact of the Cleaning Process on Sterilization Validation and Biocompatibility Activities The achievement of a suitable level of cleanliness in the manufacturing of medical devices is an indispensable precondition to providing patients, users and...