White Papers

Why Choose GLOBAL?

The CRO with a Proven Track Record in Medical Device and In-Vitro Diagnostic (IVD) Regulatory Consulting and Writing Services

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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.

Five Tips and 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).

Tools to Aid in Inspection Readiness - A Two Part Guide

Inspection happens. This white paper provides some guidance on how to be ready with purposeful documentation and planning. The authors also provide tips on creating an Action, Decision, and Issues (ADI) and how to storyboard for success.