Notified Body Submission Support & Approval
Complete support for Notified Body submissions and CE certification for your medical devices.
- Regulatory Focused
- Expert Team
- Submission Support
- Global Market Access
- Faster Time-to-Market
OVERVIEW
What Is Notified Body Submission?
We help medical device companies prepare and submit documentation to Notified Bodies for CE certification under EU MDR, with accurate documentation and regulatory support.
OUR SUPPORT INCLUDES
Our Support Includes
Gap Assessment & Strategy
Identify requirements and prepare the right submission strategy.
Technical Documentation Support
Prepare complete technical documentation as per EU MDR.
Notified Body Submission
Manage submission and coordination with the Notified Body.
Notified Body Communication
Support queries and communication during the review process.
Review Support
Prepare responses to Notified Body questions.
Approval & Certificate Support
Support until successful CE certification.
OUR PROCESS
Our Process
01
Assess
Understand requirements and identify gaps.
02
Plan
Prepare documentation and submission strategy.
03
Submit
Submit to the Notified Body and manage review.
04
Approve
Support until CE certification.
KEY DELIVERABLES
Key Deliverables
- Technical Documentation (EU MDR)
- Risk Management File (ISO 14971)
- Clinical Evaluation & Post Marketing Surveillance
- Labeling and IFU Documentation
- Submission Dossier
- CE Certification Support
WHY CHOOSE MEDSCAPE?
Why Choose Medscape?
EU MDR Expertise
Accurate Documentation
Notified Body Support
End-to-End Guidance
Ready for Notified Body Submission?
Get expert support for your CE certification journey.