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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.
How to Prepare for a Clinical Audit
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 [...]
Unpacking State-of-the-art: Why Does It Matter to My Medical Device Clinical Evaluation?
The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since it was first drafted, some of which cannot be repeated here. One thing it has probably never been called is [...]
Fundamentals of Clinical Evaluation Reports: A Beginner’s Guide
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 [...]
An Overview of the CE Marking Process in the European Union
You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and the guidance documentation, you begin to doubt the CE mark process. Are [...]
5 Major Concerns for Software As a Medical Device and AI Companies
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 [...]
Top 10 Literature Search Tools Every Medical Writer Should Know
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 [...]