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Document Review: A Nuanced Process in Medical Writing
Veranex is determined to provide complete support to our healthcare partners to reach our shared goal of advancing medical care and improving patients’ quality of life. Our integrated, comprehensive solutions support every stage, from concept to commercialization. In...
Case Study: Determining Daily Fertility Through an App that Tracks Basal Body Temperatures and Period Data
New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts?
The EU Commission recently published (January 23, 2024) a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring availability of safe devices that are essential for healthcare systems. With this...
Amending Regulation for MDR / IVDR: Key Takeaways for the Diagnostics Industry
Yesterday, the EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of safe devices that are essential for healthcare systems. The amending regulation extends the transition...
2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
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 the device's risk class (Yes, even class A devices require a proper performance evaluation!). As...
Veranex Design Control Guide
Veranex Design Control Guide Effectively managing all design control requirements can be a smooth process, if planned and implemented in line with the product, business goals and regulations to avoid challenges for medical device manufacturers. To assist...
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:...