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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.
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 [...]
Post-market Clinical Follow-up (PMCF): What you Need and How to Get It
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 [...]
Understanding Literature Review and Clinical Data Trends
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 [...]
The Top 5 Regulatory Requirements for the Medical Device Industry
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 [...]
Why Your EU MDR Literature Review is Your Clinical Evaluation Bottleneck
Clinical evaluations for medical devices are long and arduous tasks. But what many medical device manufacturers fail to take into consideration is that clinical evaluations are living processes. They ebb and flow. And [...]
Understanding Global Regulatory Authorities in the Medical Device Industry
You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants medical devices that are unsafe. Seriously, there is literally not one sane [...]