In the pharmaceutical industry, a Quality Management System (QMS) is the backbone of your compliance...
Life Sciences Blog
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Life Sciences Blog
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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...
Medical Device Software (MDSW) development can feel like a regulatory labyrinth, especially for star...
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 the ever‑evolving life sciences industry, digitization is no longer optional — it’s a strategic i...
A Laboratory Information Management System (LIMS) is more than just software; it’s the operational b...
In vitro diagnostic devices (IVDs) play a critical role in modern healthcare. From disease diagnosis...
As of February 2, 2025, Article 4 of the EU AI Act is in force. This means AI providers and deployer...
In regulated environments such as pharmaceutical manufacturing, laboratory research, and clinical tr...
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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...
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...
The life sciences landscape is vast, complex, and rapidly changing, so it can be hard to navigate. V...
Scientists outside of science Many scientists catch the research bug as children. For some, the inci...
So, you’ve made a huge breakthrough on a project you’ve been working on forever, or found that your ...
Getting monetary value out of all your R&D efforts is key to the long-term success of your busin...
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 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...
The AI Act was formally adopted by the full European Parliament on 13 March, and we have reviewed th...
We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Boga...
In earlier blog posts, we spotlighted the EU member states – Germany, Belgium, and France – and thei...
U.S. Basic Requirements for DTx Products Subject to the U.S. Health Authority (FDA) regulations, spe...
Germany has always been renowned for its meticulous attention to detail, often described by the term...
All Digital Therapeutics (DTx) must adhere to the EU’s foundational CE marking requirements as detai...
In a landscape marked by escalating healthcare expenses and budgetary restrictions, mobile health (m...
In the rapidly evolving pharmaceutical industry, computerized systems play a vital role in drug deve...
Any company in the pharmaceutical or medical device industry with a certified GMP, GDP or ISO 13485 ...
A job in life sciences consultancy offers plenty of challenges, variety, career opportunities, and g...
Ever wondered why it is necessary – and sometimes absolutely essential – to perform a Data Migration...
Changes in business needs or technology are inevitable. They often lead to the retirement or “decomm...
Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in ...
During the pandemic, electronic signatures gained tremendous importance for companies in heavily reg...