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
Responsible AI in Medical & Regulatory Writing: Why Expert Oversight Matters
Generative AI tools are starting to revolutionize how many industries engage with regulatory obligations. We discuss the opportunities and challenges in working with AI, and outline how our team of medical writers can support your project to ensure quality submissions.