Latest Publications

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 links [...]

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 [...]

Audits are not fun. That's general knowledge. Ask anyone, and they will tell you. But they will also tell you that being audited is a normal part of being in the industry.   There are [...]

The clinical evaluation reports are the final transcript for medical devices. Allow us to explain. So, you know how in high school, you had to earn good grades and maintain a solid record to impress [...]

Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices are becoming smarter than ever, analyzing data faster than ever and creating regulatory [...]

Medical writing is hard. It's tricky, technical, and sometimes exceptionally tedious. Suppose you chose literature reviews as your niche or form part of the regulatory staff selected for clinical evaluations. In that case, I'm sure [...]

With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, respectively), the requirements for clinical evidence were increased by the regulatory authorities. 1 Part of [...]