Your EU MDR Lifeline
Has Arrived

100% Success Rate Submission Work – On a tight timeline!

PMCF Pricing

What Do You Need?

I need audit support, yesterday!

I have questions, or want an expert review of my documents before I submit

I’m looking for general writing and support

How It Works

We go over your project

(15-20 Minutes) is usually all it takes to understand your situation, and give you some ideas on strategy/pricing.

We review your documents and send a proposal

(1-2 Days) If aligned on strategy, we’ll take a deeper dive into your documents, and prepare a plan of action, complete with timeline and pricing.

We deliver

(TBD) Our team boasts lightnening fast turnaround on all MDR project types if you’re facing a tight timeline or a tricky auditor.

A Track Record You Can Bet On

Experienced Staff On-Demand


The Ten Most Common MDR
Non-Conformity Mistakes

(and how to fix them)

For manufacturers looking to strengthen their Clinical Evaluation and Post Market Surveillance related documents and sail through their Audits.

We’ve seen more than enough Notified Body feedback to last a lifetime. This report is a summary of our findings, and how to address them.

EU MDR Problems We Solve

Audit Feedback and Non-Comfority Correction

CER Drafting, Updating,

Gap Assessment, and ‘Audit Readiness’ Reviews

Post Market Surveillance and Clinical Follow-Up

MD Clinical Reviewer

What are you waiting for?

Whether you’re up against it with your submission or still in the information gathering phase, speaking with one of our experts can only help (and it’s free).