Clinical Evaluation & Post Marketing Surveillance
Complete support for clinical evaluation and post-market surveillance for your medical devices.
- Regulatory-Focused
- Expert Team
- Submission Support
- Global Market Access
- Faster Time-to-Market
OVERVIEW
What Is Clinical Evaluation & Post-Market Surveillance?
We help medical device companies prepare Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and establish Post-Market Surveillance (PMS) processes as per global regulatory requirements.
OUR SUPPORT INCLUDES
Our Support Includes
Gap Assessment & Strategy
Identify clinical evaluation requirements and prepare the right strategy.
Clinical Evaluation (CEP)
Develop a comprehensive CEP as per regulatory standards.
Clinical Evaluation Report (CER)
Prepare CER with clinical data analysis and literature review.
Literature Search & Clinical Data Analysis
Analyze clinical data and relevant literature to support clinical claims.
Regulatory Submission Support
Support for clinical evaluation documentation for regulatory submission.
Post-Market Surveillance (PMS)
Establish and maintain PMS processes and documentation.
OUR PROCESS
Our Process
01
Assess
Understand your device and clinical requirements.
02
Plan
Prepare clinical evaluation strategy and plan (CEP).
03
Develop
Compile clinical data, conduct analysis, and prepare the CER.
04
Maintain
Support PMS activities and ongoing updates.
KEY DELIVERABLES
Key Deliverables
- Clinical Evaluation (CEP)
- Clinical Evaluation Report (CER)
- Clinical Data Analysis
- Literature Review Summary
- Post-Market Surveillance (PMS)
- PMS Reports and Updates
WHY CHOOSE MEDSCAPE?
Why Choose Medscape?
Expert Team
Accurate Documentation
Regulatory Guidance
End-to-End Support
RELATED SERVICES
Related Services
Ready to Prepare Your Clinical Evaluation?
Get expert support for CEP, CER, and PMS documentation.