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
Vistatec Partnership
A few months ago, we announced our partnership with Vistatec Life Sciences. This partnership delivers integrated, accurate, translated regulatory writing combined with expert localization expertise that helps organizations accelerate global submissions with clarity, confidence, and compliance.
Proposed Changes to EU MDR: What Manufacturers Need to Know
The European Commission has proposed a series of updates to the EU Medical Device Regulation (MDR) aimed at improving efficiency, reducing burden, and addressing long-standing bottlenecks—particularly around Notified Body capacity, classification clarity, and clinical requirements.