You Have Medical Device Questions – We Have Answers

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Specialized EU MDR & IVDR Consulting Services

CiteMed’s EU MDR consultants have helped startups, SMEs, and enterprise manufacturers navigate the full complexity of European regulatory compliance.Whether you need hands-on EU MDR consulting, dedicated IVDR consulting for in vitro diagnostics, or support across the entire submission process — we bring the experience to get it done right.

Who We Help

Contract Research Organizations

Individual Medical Writing Freelancers

Software as Medical Device Companies

Small/Medium Size Manufacturers

Startup Medical Device Manufacturers

Medical Device Manufacturers Enterprise

Problems We Solve

Clinical Evaluation, Literature Review

EU MDR & IVDR Consulting Support

Post Market Surveillance

Gap Assessment

Emergency Audit Support

FDA 510K Submission Support

What It’s Like Working With CiteMed

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?
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Project Types:

EU MDR & IVDR Consulting

Our EU MDR consultants provide document review, full CERs, and Notified Body response support. Whether you need hands-on EU MDR consulting or dedicated IVDR consulting, we help your team navigate the requirements with confidence.

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.

Post Market Surveillance

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.

Emergency Audit Support

Emergency 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 Quote?
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!