February 17, 2023
Are you shopping for CER writers? Or perhaps trying to evaluate if this is the type of document you can make work yourself? Then this article is for you. With the transition to [...]
February 21, 2023
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for the in [...]
February 18, 2023
Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is essential to [...]
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 links [...]
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 [...]
October 17, 2023
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 [...]
October 10, 2023
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 [...]
October 3, 2023
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 [...]
September 19, 2023
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 [...]