IVD Regulatory Services by MDx CRO
IVD news August 9, 2023At MDx CRO, our specialized IVD regulatory services cater not only to in vitro diagnostic medical device manufacturers, companion diagnostics... read more
Companion Diagnostics IVD Consultancy within the EMA Framework: Comprehensive Guidance
IVD news August 8, 2023The field of companion diagnostics IVD (CDx) represents a confluence of technological innovation, regulatory compliance, and patient care. As personalized... read more
Influenza Assays: Risk Classification Under IVDR
IVD news July 27, 2023New position statement published by the IVD expert panel on influenza viruses MDx CRO, an IVD consultancy and CRO company,... read more
IVD Consultancy: Balancing Expertise & Cost-Efficiency with MDx CRO
IVD news July 27, 2023Striking a balance between expertise and cost-efficiency in IVD consultancy can be a tricky task, especially within the European Union’s... read more
Clinical Molecular Genetics (CMG) Under the Lens of the EU IVDR, MDCG and MEDDEV.
IVD news July 24, 2023At the crossroads of healthcare and technology, Clinical Molecular Genetics (CMG) emerges as a keystone, bridging molecular biology and genetics... read more
MDR Transition Period: Updated Q&A Document, Changes & Clarifications
MEDTECH news July 20, 2023The recent amendment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) through Regulation (EU)... read more
IVDR Compliance: Progress in EU Reference Laboratories and consequences for High-Risk IVDs
IVD news June 22, 2023EU Commission evaluates EURLs The European Commission is making significant progress in evaluating applications for EU reference laboratories (EURLs) to... read more
How to Prepare Your Clinical Evaluation Plan Template in 5 Key Steps
MEDTECH news June 9, 2023In this article, we will delve into the intricacies of developing a robust Clinical Evaluation Plan using expert regulatory terminology,... read more
Companion diagnostic studies: BSI & TÜV SÜD Lead the Way in CDx Certification
IVD news June 6, 2023The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies... read more
MDR Annex XVI: Regulating Medical Devices Without An Intended Medical Purpose
MEDTECH news June 2, 2023How are medical devices without an intended medical purpose regulated under the MDR Annex XVI? Continue reading to learn more.
New Regulation on In Vitro Diagnostic Medical Devices in Spain: Are You Ready?
IVD news June 2, 2023Are you ready for the new regulation on In Vitro Diagnostic medical devices in Spain? Learn everything you need to... read more
Clinical Investigation Report for Medical Devices (2023/C 163/06): Preparing your CIR template
MEDTECH news May 10, 2023Following the end of a clinical investigation and irrespective of its outcome, the Regulation (EU) 2017/745 (MDR) and the International... read more
What is the Regulatory Process for IVD in Europe?
IVD news May 10, 2023What is the regulatory process for IVD in Europe, and which are the most important aspects of it? Continue reading... read more
IVDR Compliance Made Easy: The Importance of an IVDR Pre-Submission Assessment by MDx CRO
IVD news May 3, 2023What are the most important things you’ll need to know when it comes to IVDR pre-submission assessment? Continue reading. The... read more
IVD Clinical Trials: The Do’s and Don’ts
IVD news April 26, 2023What are some of the most important things you’ll need to know for IVD clinical trials? Continue reading to learn... read more
Impact of Spain’s Real Decreto 192/2023 on Clinical Investigations with Medical Devices
MEDTECH news April 22, 2023The field of medical devices is continually evolving, with new technologies and innovative products constantly being developed to improve patient... read more
IVD Software Development: How to Bring IVD Software to Market in 8 Steps
IVD news April 4, 2023The healthcare industry is undergoing a rapid transformation spurred by the advent of advanced medical diagnostic technology. IVD software development... read more
EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions
MEDTECH news March 27, 2023In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of... read more
MDR Clinical Evaluation Report: The Roles of MEDDEV and MDCG Explained
MEDTECH news March 19, 2023The EU Medical Device Regulation has introduced significant changes to the requirements for clinical evaluation reports of medical devices. This... read more
IVDR technical documentation guidance released by Team-NB
IVD news March 13, 2023If you are still undecided on which Notified Body (NB) to choose or you are in the early stages of... read more
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