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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.
Economic Obstacles in EU MDR and How we are Overcoming them
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 [...]
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 [...]
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 [...]