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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.
Pressure to Cut Corners in EU MDR Compliance?
Inflation has been upon us for some time, affecting almost every business, including medical device clinical evaluation and regulatory compliance. Since the cost of living, materials, and services have increased, manufacturers are struggling to meet [...]
Updating the Literature Review and Literature Search Protocol
Getting the long-awaited CE mark is certainly something to celebrate, so if you got it, congratulations! Now you just have to make sure to keep it! While the preparation for the device launch (which [...]
Post-market surveillance under the IVDR: Frequently Asked Questions
Requirements for post-market surveillance (among a host of other requirements for everything from classification to clinical follow-up) were never that elaborate in the In Vitro Diagnostics Directive (IVDD; 98/79/EC). However, with the introduction of [...]
Best Systematic Literature Review Software
A systematic literature review is one of the most important stages of the CER process, but it's also time-consuming and labor-intensive. Literature review software tools make the process a little easier by streamlining the [...]
Tips and Tricks for How to Conduct a Literature Review with Endnote
The literature review is a critical part of any clinical evaluation. It's where you collect all of your clinical data, analyze it, weigh it, and use it to evaluate the acceptability of your device's risk-benefit [...]
A Targeted Approach to EU MDR
The European Union Medical Device Regulation (EU MDR) is easily one of the major changes in the last decade that altered the medical device sector in the European Union. The goal was to improve [...]