How Literature Review Automation Improves Performance Evaluation Reports (PER) Program Management for the IVDR

By |2022-12-15T13:13:02+00:00December 14th, 2022|

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 for manufacturers to ensure that the IVDR has been constructed according to current regulatory requirements and that it is based on [...]

Five Practical Tips For Clinical Literature Review

By |2022-12-15T13:11:22+00:00September 27th, 2022|

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 data to evaluate your device's safety, benefit, and risk in an evidence-based manner.   Since the medical device literature reviews [...]

Term Refinement in Literature Search

By |2022-12-15T13:14:04+00:00May 31st, 2022|

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 manufacturer, including obtaining data necessary to create evidence-based recommendations and design, data regarding the device technology's effectiveness, and risk assessments. [...]

Can Artificial Intelligence Technology Tame Literature Review?

By |2022-12-15T13:14:06+00:00May 3rd, 2022|

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 an entire year to read through and database. And this problem is not only for scientists only. Any company or [...]

The Relationships Between Literature Search and CER and PMS Vigilance, PMCF, and PSURs

By |2022-12-15T13:14:07+00:00April 19th, 2022|

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 objective of the literature search is to obtain information about the safety and performance attributes of similar products for which [...]

Performing Effective Literature Search – For EU MDR and Other Regions

By |2022-12-15T13:15:31+00:00March 8th, 2022|

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 is a comprehensive and systematic literature search which is performed to identify suitable clinical data that is not available from [...]

MEDDEV 2.7.1 Revision 4: Guidelines for Literature Search

By |2022-12-15T13:15:36+00:00January 11th, 2022|

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 how the literature search should be conducted, the MEDDEV 2.7.1 revision, 4 is the primary document that provides "general guidance on a [...]

Effectively Handling Corrective and Preventive Actions (CAPA) Process with EU MDR

By |2022-12-15T13:15:37+00:00January 3rd, 2022|

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 actions should also be simultaneously integrated in CAPA management for best outcome.   Corrective and preventive actions (CAPA) should seamlessly [...]

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