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.
