Check Out Our Latest Interview!
Our head of Regulatory Ed Drower was just recently interviewed on the Easy Medical Device Podcast to discuss MDR Literature Search best practices and other research topics.
Latest Publications
Look here for Industry updates and technical tutorials written by the CiteMed staff. All things Medical Device Regulation are covered in our publications.
Medical Device Notified Body Feedback – EU MDR: A Case Study
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, [...]
Switzerland’s Medical Device Regulation and the EU Regulations
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 [...]
EU MDR: Combination Products – An Overview
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 [...]
Free EU MDR Templates – Download Here
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 [...]
ISO Standards for Medical Devices: What they are and When you Need Them
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 [...]
In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges
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 [...]