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Clinical Evaluation Reports (CER)
We conduct systematic literature searches, evaluate clinical data dossiers, and draft clinical evaluation reports (CER) to establish the safety and performance of your medical device for regulatory submissions.
Key Benefits
- Conforms to global guidelines (MEDDEV 2.7/1 Rev 4 & EU MDR Annex XIV)
- Expert medical writing led by qualified clinical research consultants
- Rigorous literature reviews preventing Notified Body safety queries
Recognized Standards
Our Methodology
1
Literature Review
Conduct systematic database searches (PubMed, Embase).
2
Data Analysis
Assess and weigh clinical evidence from literature and trials.
Required Documents
Clinical Evaluation Report (CER)
Literature Search Protocol
Post-Market Clinical Follow-up (PMCF) plan
Common Questions
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