December 14, 2022
A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the safety evaluation of a medical device product. Literature reviews are essential [...]
August 9, 2022
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With the slow but [...]
July 26, 2022
While post-market clinical follow-up (PMCF) played a part in the MDD (Directive 93/42/EEC), the updated Medical Device Regulation (MDR, 2017/745) introduced stricter rules for [...]
December 19, 2023
The medical device industry is fueled by innovation. Research and development are the blood that keeps it going. Each day, we advance a little more to better human health. Thousands of people worldwide work [...]
December 12, 2023
The medical device development process is not a one-step operation. Instead, it is a multi-phase process requiring meticulous planning and implementation so that you get a safe and effective device at the end of [...]
December 5, 2023
Developing a medical device is not a one-step process. There are hundreds of little steps, from drawing the design to finalizing it to actually creating the device. Between all these steps, there is always [...]
November 28, 2023
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 [...]
November 21, 2023
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, [...]
November 14, 2023
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 [...]
November 11, 2023
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 [...]
October 25, 2023
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 [...]
October 24, 2023
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 [...]