EU MDR

The medical device regulatory sector is always changing. It has to. In order to keep up with the ever-changing medical devices and tech, regulatory bodies need to develop new laws that apply to new [...]

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 [...]

We all know and love (ahem) the EU MDR (2017/745). And although it is defined as the EU Medical Device Regulation, it applies to certain other devices as well. The continued innovation of the [...]

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 [...]

The whole point of medical devices is to improve patient safety and patient quality of life. That's it, that's the gist.   To do that, medical devices need to work, and they need to be [...]

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 [...]

As a medical writer, one of the biggest weapons in your arsenal is a well-written, well-researched literature review. It is one of the most wonderful documents that can produce a wealth of information when used [...]

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 [...]

Clinical evaluations for medical devices are long and arduous tasks.   But what many medical device manufacturers fail to take into consideration is that clinical evaluations are living processes.   They ebb and flow. And [...]

You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants medical devices that are unsafe. Seriously, there is literally not one sane [...]

Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But when it comes to the equivalent for in vitro diagnostic medical devices, the performance evaluation, most of us are a [...]