White Papers & GLOBAL Guides

Designed to be educational, our white papers take a deep dive into important regulatory topics and our GLOBAL Guides provide readers with an overview of regulatory topics and industry resources.
GLOBAL Guide

Why choose GLOBAL? A Proven Track Record in Medical Device and In-Vitro Diagnostic (IVD) Regulatory Consulting and Writing Services.





White Paper

5 Tips & Tricks Developing a Comprehensive Performance Evaluation Plan (PEP). Have a new in vitro diagnostic seeking approval? Transitioning a legacy device from compliance under IVDD to compliance under IVDR? Check out our tips and tricks for starting the performance evaluation process under EU Regulation 2017/746 (IVDR).

White Paper

The Impact of COVID-19 on the Medical Device Regulation (MDR). This white paper provides details on the impact COVID-19 has had on the implementation of the Medical Device Regulation (MDR), implications for medical device companies, and actionable steps companies can take to use this delay to position them for success.

GLOBAL Guide

How to Write a Protocol Synopsis for Laypersons. Clinical Trials Information System (CTIS) requires sponsors to provide both a protocol synopsis and a lay summary of the study's results. Here are some tips for success.