Blogs Topic: Medical Device Regulatory Submissions

medical device REGULATORY submissions

PHARMA & BIOLOGICS REGULATORY SUBMISSIONS

TECHNOLOGY

GLOBAL INSIGHTS

DEI IN REGULATORY WRITING

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.

medical device REGULATORY submissions

PHARMA & BIOLOGICS REGULATORY SUBMISSIONS

TECHNOLOGY

GLOBAL INSIGHTS

DEI IN REGULATORY WRITING

What Is a 510(k)?

The 510(k) pathway may be well established, but success depends on precision and clarity. With deep experience across medical device categories and FDA submission types, our team at GLOBAL helps you bring safe, effective technologies to patients—faster and with confidence.

medical device REGULATORY submissions

PHARMA & BIOLOGICS REGULATORY SUBMISSIONS

TECHNOLOGY

GLOBAL INSIGHTS

DEI IN REGULATORY WRITING

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.

medical device REGULATORY submissions

PHARMA & BIOLOGICS REGULATORY SUBMISSIONS

TECHNOLOGY

GLOBAL INSIGHTS

DEI IN REGULATORY WRITING

Writing High-Quality CSRs: Common Pitfalls and How Expert Support Can Help

Whether you’re submitting to the FDA, EMA, or another authority, the CSR must tell a clear, compliant, and credible story of your trial. GLOBAL's Medical Writing team shares tips and tricks to get it right.

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.

Medical Device Regulatory Submissions

Proposed Changes to EU MDR: What Manufacturers Need to Know

What Is a 510(k)?

What is IVDR?

Writing High-Quality CSRs: Common Pitfalls and How Expert Support Can Help

Strategic Considerations for Partnering with a Vendor for EU MDR Deliverables

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

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

PSURs: Obstacles with Pending MDR Approval

Interview with the Med Device Team of Medical Writing Consultants

How to Strengthen Your Technical Writing

EU MDR CER Requirements in 2025

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