Literature Search and Literature Review

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 [...]

A literature search is a systematic search through existing data in an organized way to determine an extensive range of quality references to a specific subject.   Literature searches serve many functions for a medical [...]

When one tries to publish in an international journal these days, they inevitably encounter an obstacle: researchers around the world have more than likely published thousands of papers on a similar topic, which could need [...]

A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices.   The [...]

For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One of the most crucial components for a thorough and complete Clinical Evaluation [...]

The work of a literature review is not merely to be submitted as a part of the submission document. A good literature review can do half of the job for the marketers developers alike, all [...]

The MEDDEV 2.7.1 is the most important technical guidance document for literature search under the MDR in the medical device regulatory industry. Since the MDCG documents do not currently offer any concrete guidance on [...]

The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive [...]

The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation of the available clinical data. In May 2021, the European Medical Device Directive (93/42/EEC) was replaced with the Medical Device [...]

Periodic Safety Update Reports:  Why You Might Need One Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually? [...]

Cost Savings of Literature Searches in Your CER Introduction We recently had a client that wanted to weigh the option of outsourcing their entire CER project overseas to more attractively [...]