Medical Device Regulatory Submissions

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

Strategic Considerations for Partnering with a Vendor for EU MDR Deliverables

GLOBAL is a leading partner for regulatory writing and consulting, and in this post, we discuss key considerations for determining when to retain work internally and when to engage a trusted third-party partner.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

Common Notified-Body Findings in EU MDR Clinical Evaluation Reports and How to Avoid Them

In this post, we outline the most frequent CER findings cited by Notified Bodies and offer practical strategies to help you avoid them.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

What Is a Clinical Evaluation Report (CER)? A Beginner’s Guide for EU MDR Compliance

Learn what a CER is and what you need to submit successfully.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

PSURs: Obstacles with Pending MDR Approval

Tips on how to navigate challenges when writing PSURs.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

Interview with the Med Device Team of Medical Writing Consultants

Learn tips and tricks about team resourcing from our Medical Device Senior Managers Beth Meier and Luke Baker.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

How to Strengthen Your Technical Writing

In this post, Jennifer Signore, PhD, Associate CER Writer, shares four tips to strengthen your technical writing skills.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

EU MDR CER Requirements in 2025

Discover what’s changed in EU MDR Clinical Evaluation Report (CER) requirements over the last five years. Learn how MDCG guidance impacts your strategy and what you must do in 2025 to stay compliant with regulators and Notified Bodies.

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