Who We Help
Problems We Solve
What It’s Like
Our Device Experience
All Device Risk Clarifications
Class I – III
Software as Medical Device
Want to see more examples of our experience?
Drop us a line to chat.
Clinical Evaluation has been our core focus for years. Don’t hesitate to pick our brains for some very hard earned expertise.
Document review, full CERs, Notified Body response support. We can help your team jump through the seemingly endless hoops of MDR and IVDR.
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.
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.
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.
All things FDA Medical Device! We’d be glad to support you in any part of the submission process.
World Class Service –
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?
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!