cer medical device, regulatory writing, & more
Industries We Serve:
Medical Devices/IVDs
Here’s How We Can Help
GLOBAL’s Medical Device and IVD Division is dedicated to supporting your regulatory and compliance needs with a comprehensive suite of services. Our expertise includes:
Medical and Regulatory Writing including CEP/CERs, PMCF & PMS Plans/Reports, PSURs, SSCPs, and Literature Reviews
Project Management including schedule creation and full-service project management of EU MDR Deliverables
Regulatory and Technical Consulting including CER Strategy, PMCF strategy, SOP review, and template review
Training including our regulatory writing internship program, CER Essentials Course, and custom training programs
Delivering Regulatory Services that Make a Real Difference.
Regulatory Writing
Consulting Services
Additional Services
GLOBAL Resources
What is IVDR?
The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) is the European Union’s regulatory framework governing in vitro diagnostic medical devices—tests and instruments used to examine human samples like blood or tissue. For manufacturers, understanding the IVDR is essential for maintaining or gaining access to the EU market.
IND vs. NDA: Understanding the Difference in FDA Submissions
For drug developers, FDA approval is a long and complex journey. Two of the most important milestones on this path are the Investigational New Drug (IND) application and the New Drug Application (NDA). While both are critical submissions, they serve very different purposes.