Clinical Evaluation Services
Clinical evaluation is a critical process for demonstrating that a medical device meets the essential safety and performance principles for its intended use — a mandatory regulatory requirement throughout the entire product lifecycle. Through systematic collection, appraisal, and analysis of clinical data, producing a scientifically rigorous Clinical Evaluation Report (CER) is the cornerstone of successful market access and ongoing compliance.
We provide professional, efficient, and regulation-specific clinical evaluation technical services to medical device manufacturers worldwide, strictly following the latest guidance from China's NMPA and EU MDR (EU) 2017/745. Our services cover all core stages from developing the Clinical Evaluation Plan (CEP) and conducting systematic literature searches and analyses, to writing the complete CER.
SERV 1. Clinical Evaluation AI Assistant Deployment Service
Cloud-deployed dedicated server providing AI-assisted clinical evaluation documentation. See Medical Device Compliance AI Assistant.
SERV 2. Complete Clinical Evaluation Service
1. Clinical Evaluation Plan (CEP) Development (EU CE marking)
- Define scope and objectives of the clinical evaluation
- Conduct State of the Art (SOTA) analysis
- Select benchmark and/or similar devices
- Perform equivalency demonstration (if applicable)
- Analyse in conjunction with risk management documentation
- Develop the Clinical Development Plan (CDP)
- Identify preclinical/clinical data to be provided by the manufacturer
- Determine literature data appraisal and analysis methods
- Develop the Literature Search Protocol (LSP)
2. Literature Search, Screening, and Data Analysis
- Select appropriate literature databases (PubMed, Embase, CNKI, etc.) per the LSP
- Execute the literature search strategy and export results
- Screen literature per pre-defined inclusion and exclusion criteria
- Extract and analyse data from included literature
- Complete the Data Collection Report (DCR) or equivalent document
3. Clinical Evaluation Report (CER) Development
- Integrate plans and analyses from the CEP (EU CE marking)
- Integrate preclinical/clinical data provided by the manufacturer
- Integrate results of literature search and analysis
- Complete the final CER per the applicable regulatory framework (NMPA/MDR)
SERV 3. Independent Literature Search and Analysis Service
Includes only the 2. Literature Search, Screening, and Data Analysis service, producing a systematic literature search, screening, and data extraction report.
SERV 2/3 Project Timeline
| Phase | Key Activities | Est. Start | Est. Duration | Deliverables | Notes |
|---|---|---|---|---|---|
| Phase 1 | Project initiation, document handover | Upon agreement | 5 business days | N/A | Dependent on timely client materials |
| Phase 2 | Literature search, screening, data analysis | After Phase 1 | 5–10 business days | LSP/LSR, DCR; CEP if applicable | CEP for EU CE projects only |
| Phase 3 | CER drafting and internal review | After Phase 2 | 3 business days | CER draft | Full service only |
| Phase 4 | Client review, revision, finalisation | After Phase 3 | 5 business days | Final CEP/LSP/LSR/DCR/CER | / |
Service Pricing
Base fee: ¥84,000.00 (covers up to 500 references)
- CEP: ¥25,200 (30%)
- Literature Search & Analysis: ¥33,600 (40%)
- CER: ¥25,200 (30%)
Additional fee: ¥500.00 per 50 references over 500 (rounded up)