FDA Literature Review – Class III PMS and Indication Expansion
Introduction Why FDA increasingly expects robust literature evidence for Class III devices For Class [...]
Complete Guide to Copyright and Usage for Medical & Literature Review Writers
1. Introduction: Why Copyright Matters in Scientific Writing Copyright is a fundamental yet often [...]
Turning Complex Medical Data Into Engaging Reader-Friendly Stories
Turning Complex Medical Data into Engaging, Reader-Friendly Stories How to Transform Evidence into Clear, [...]
The Post-Market Surveillance Document: Which Ones Do you Need?
It's not enough to make a device and put it on the market—you must [...]
EU Clinical Trial Regulation: What you Need to Know
For manufacturers, clinical trials or at least the protocol are already planned and set [...]
Term Refinement in Literature Search
A literature search is a systematic search through existing data in an organized way [...]
Meddev 2.7 1 Rev 4: Guidelines for Literature Search
MEDDEV 2.7.1 Rev. 4 remains the most important technical guidance document for conducting literature [...]
CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
The European Union Medical Device Regulation (EU MDR) has set higher standards for medical [...]
The UK MDR and The EU MDR: What Are The Differences?
UK MDR is the primary standard that mandates requirements for anyone selling medical products [...]
PMCF Plan EU MDR: What You Need and How to Create It
One of the new aspects introduced in the European Medical Device Regulation 2017/745 (MDR) [...]