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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.
Performance Plan Evaluation Under the EU IVDR 2017/746
Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But when it comes to the equivalent for in vitro diagnostic medical devices, the performance evaluation, most of us are a [...]
MDR Notified Bodies: Answered
Navigating the complex regulatory landscape as a medical device manufacturer is pretty difficult. Especially when you have to deal with tons of complex jargon, laws from god knows where, and experts like the notified body [...]
PMCF for IVDR and MDR – A Case Study and How-To
By now, most of us have struggled through at least one successful submission for MDR/IVDR, and we know they take time. Very doable, but no ones exactly surprised at home simple everything was to [...]
Common Obstacles to a Great Medical Literature Review Under the EU MDR
Medical device literature reviews are mandatory for any clinical evaluation under the EU MDR. More importantly, they are essential for medical device manufacturers looking to establish or confirm their medical devices' benefit/risk profile through clinical [...]
EU MDR Cybersecurity: Safeguarding Medical Devices in the Digital Age
In the fast-paced world of healthcare, there are always concerns regarding any new medical device. The concern about cybersecurity in medical devices or, in plainer words, getting hacked or getting your data out on [...]
EU MDR State-of-the-Art: Tips and Tricks
Do you know the crucial part of every medical device clinical evaluation? Yep, you guessed it - the state-of-the-art section! This part might not be the trickiest, but trust me, it comes with its [...]