Literature Search and Literature Review

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is essential to the clinical evaluation process for medical devices. The clinical evaluation [...]

A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the safety evaluation of a medical device product.   Literature reviews are essential [...]

The European Medical Device Regulation (MDR) outlines the requirements for the literature review needed for the clinical evaluation of medical devices. You need a robust process for performing your literature review and finding clinical [...]

The research process is often thought of as a linear, straightforward path. You begin with a question and then proceed to find the answer. But, in reality, research is a messy process that often involves [...]

Literature reviews are an essential part of the clinical evaluation process for medical devices. The clinical evaluation report assesses a medical device's benefit-risk profile to ensure its continued safety, efficiency, and compliance. Most regulatory [...]