The clock is ticking for medical device manufacturers operating in the European Union as we move tow...
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If you are a manufacturer of medical devices or in vitro diagnostic (IVD) devices based outside Swit...
For medical device and in vitro diagnostic (IVD) manufacturers located outside the United Kingdom, a...
For medical and in vitro diagnostic device manufacturers based outside the European Union, accessing...
As global clinical trials grow in scale and complexity, integrating In Vitro Diagnostics (IVDs) into...
The use of in vitro diagnostic (IVD) devices in clinical trials has become increasingly complex unde...
In vitro diagnostic devices (IVDs) play a critical role in modern healthcare. From disease diagnosis...
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Next-Generation Sequencing (NGS) has revolutionized precision oncology. By enabling the simultaneous...
The In Vitro Diagnostic Regulation (IVDR) in the EU is widely considered one of the most rigorous re...
In the In Vitro Diagnostic (IVD) medical device industry, adhering to regulatory requirements is par...
We’re proud to highlight a new publication by Pieter Bogaert, PhD—senior RA IVD consultant at QbD Gr...
The In Vitro Diagnostic Regulation (IVDR) represents a major shift in the regulatory landscape for I...
In May 2022, the European Union (EU) ushered in the In Vitro Diagnostic Regulation (IVDR), marking a...
Understanding IVDR requirements To leverage the transitional provisions and ensure compliance with I...
In the In Vitro Diagnostic Medical Devices (IVD) manufacturing landscape, compliance with regulatory...
With the European Commission’s proposal for extending the transitional period for In Vitro Diagnosti...
In the dynamic landscape of medical device regulations, the recent proposal by the European Commissi...
We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Boga...
The rules outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) ...
PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance o...
In vitro diagnostic (IVD) medical devices (Manufacturers | Internal Market, Industry, Entrepreneursh...
In vitro diagnostic medical devices (IVDs) have long been a part of our healthcare industry. Recentl...