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...

In the In Vitro Diagnostic (IVD) medical device industry, adhering to regulatory requirements is par...

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...

At the beginning of yet another new year, it is always interesting to take a moment to reflect on th...

Current regulations require that manufacturing processes in the pharmaceutical industry be validated...

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...