You Have Medical
Device Questions

– We Have Answers

You have medical device questions hero consulting services 040423

Who We Help

Medical Device

Software as Medical
Device Companies

Startup Medical
Device Manufacturers

Individual Medical
Writing Freelancers

Size Manufacturers

Contract Research

Problems We Solve

Clinical Evaluation,
Literature Review


Submission Help

Audit Support

Post Market

FDA 510K
Submission Support

What It’s Like
Working With

Our Device Experience

All Device Risk Classifications

– Covered

Class I – III

Software as Medical Device

Combination Products

Want to see more examples of our experience?
Drop us a line to chat.

Project Types:

Clinical Evaluation,
Literature Review

Clinical Evaluation has been our core focus for years. Don’t hesitate to pick our brains for some very hard earned expertise.

Submission Help

Document review, full CERs, Notified Body response support. We can help your team jump through the seemingly endless hoops of MDR and IVDR.

Post Market

Templates, Software Tools, Completely Handled PMS Services, and everything in between. Use our complete-and-compliant solutions to get up to speed fast, or just our tools/templates to build your own.

Gap Assessment

Looking for a second opinion on your documents/plan in the US or Europe? Get a detailed reviewed from one of our experts with your specific submission type experience.

Audit Support

We’ve all had a mind boggling set of audit questions / non-conformities sent our way. Use our team to help draft responses, clarify issues, or get your documents up to speed.

FDA 510K
Submission Support

All things FDA Medical Device! We’d be glad to support you in any part of the submission process.

World Class Service –
Unmatched Experience

Single Point of Contact –
Dedicated Account Managers
for each project and client.

Your Timelines and Project Risk Managed

Things happen, new issues spring up, needs and requirements can change.

We get it. Which is why we’ve spent so much time over the years perfecting our project and change management processes.

Each week you’ll receive a summary from your point of contact, detailing any new issues/concerns and their potential ‘risk’ to the project timeline.

Communication is our culture. You’ll never go multiple days wondering ‘what is happening with my project’.

Have a Question?
Need a Qoute?
Let’s Talk.

We’re happy to talk through your current challenges and see if we’d be a match to help. All of our consultations are free, and it’s our hope that you walk away from the call with not only some pricing information but some valuable insight to help with your projects.

Help is only a few more clicks away!