As global clinical trials grow in scale and complexity, integrating In Vitro Diagnostics (IVDs) into...
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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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Post-Market Clinical Follow-up (PMCF) is no longer optional. Under the EU Medical Device Regulation ...
Since the Medical Device Regulation (MDR) 2017/745 came into full effect on May 26, 2021, post-marke...
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Next-Generation Sequencing (NGS) has revolutionized precision oncology. By enabling the simultaneous...
In clinical research, the success of a trial heavily depends on two key factors: recruiting enough e...
Effective site selection and qualification are the cornerstones of any successful clinical trial. By...
Picture this: you’re racing to get a promising new therapy from lab bench to patient bedside, only t...
We’re proud to highlight a new publication by Pieter Bogaert, PhD—senior RA IVD consultant at QbD Gr...
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With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical d...
1. Start with a clear intended purpose A strong clinical performance strategy begins with a well-def...
The In Vitro Diagnostic Regulation (IVDR) represents a major shift in the regulatory landscape for I...
In a previous blog post, we talked about the various activities that take place during an inspection...
In a previous blog post “Regulatory Inspection Readiness: A Proactive Approach to CAPA and Complianc...
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...
“Send” – After weeks of collaboration with the operations team, legal advisors, and experts, a detai...
With the European Commission’s proposal for extending the transitional period for In Vitro Diagnosti...
In recent discussions, the European Commission’s proposal for extending the transitional period for ...
In the dynamic landscape of medical device regulations, the recent proposal by the European Commissi...
With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Me...
We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Boga...
Medical Devices CE certified under the European Medical Device Directive (MDD) or the Active Implant...
Software Medical Devices (or Medical Device Software, as it is generally referred to in the EU), is ...
Conformity assessments for CE approval As indicated on the website of the European Commission, a med...
A comprehensive, objective, and thorough systematic literature review to describe the general State ...
Digital health in pharma is not just an emerging trend; it’s shaping the future of the pharmaceutica...
Computerized systems have become an integral part of clinical research, from data collection to anal...
State of the Art (SOTA) literature review is part of the clinical evaluation process of a medical de...
To get and maintain market approval in the EU (CE marking under MDR), state-of-the-art (SOTA) litera...
The last two years have seen significant changes in the approval management of clinical trials. In t...
In June 2022, concerns were expressed that severe challenges related to the implementation of Regula...
Nowadays, regulations on medical devices and medicinal products have very strict expectations on doc...
Digital technology is transforming the way clinical trials are conducted, offering new opportunities...
Are you performing clinical research with medical devices? In this blog post, we provide a brief ove...
‘Digital health‘ is on the rise. It’s a term we use more and more often. But what is digital health?...
Are you excited to bring your brand-new medical device to market? As you navigate the challenging pr...
Clinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, a...
Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in ...
T he global regenerative medicine market, including direct-to-consumer stem cell therapy , is expec...