Latest Publications

Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex. Navigating through these regulations requires a deep understanding of the nuances that [...]

Medical device regulations are no joke. It's pretty important to get the regulations right, since even a single missed data, if significant enough, can result in years of delay in getting a CE mark. [...]

Thinking of Hiring a Clinical Evaluation Consultant? So it's finally time to either start that new Clinical Evaluation Report (CER) project for Europe, or remediate your current documents based on Notified Body feedback... and [...]

Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat, and monitor literally all health disorders. And for this very reason, no [...]

Clinical trials are important. The discovery of any new medical treatments is a standard step for testing the device on human subjects in a safe, controlled environment where the results and process can be [...]

Getting notified feedback on your medical device clinical evaluation can be overwhelming. Even if the changes required are minimal, the feedback sheet typically doesn't look minimal. They do like their text and technical expressions, [...]

The medical device industry is thriving globally. Not only in European Union countries, but the influence is also seen in neighboring countries as well. Switzerland, in particular, has become a huge market in medical [...]

Before you begin (or continue your EU MDR Journey), make sure you're operating off of comprehensive templates. This article will cover a brief overview of our own templates (some free, some paid), and include [...]

All medical devices have their merit since all of them are used in the medical field. However, the In vitro diagnostic tools are especially essential since medical practitioners use them to identify, treat, and manage [...]

One of the new aspects introduced in the European Medical Device Regulation 2017/745 (MDR) is post-market clinical follow-up (PMCF).   While PMCF is well-known in the pharmaceutical world, it is a relatively new concept in [...]

Being in the regulatory industry is not as cut and dry as most people think. Sure, you do have to read a lot, usually till your eyes bleed, but as soon as you get [...]

The European Union Medical Device Regulation (EU MDR) is easily one of the major changes in the last decade that altered the medical device sector in the European Union. The goal was to improve [...]