EU MDR Regulatory Review Packages
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Structured, fixed-scope regulatory document reviews designed to identify compliance gaps before notified body submission.
All review requests are handled confidentially and independently.
Literature Search Strategy Design
MDR-compliant literature search protocol development
Scope: Search strategy, PICO framework, keyword definition
Delivery: 3–5 business days
What you will receive:
- Structured literature search protocol (CEP-aligned)
- Database-specific keyword strategy (PubMed, Cochrane, etc.)
- Inclusion and exclusion criteria
- Search methodology documentation
Systematic Literature Search & Screening
Comprehensive literature identification and selection
Scope: Scientific databases and vigilance data sources
Delivery: 5–7 business days
What you will receive:
- Literature search results (PubMed, Cochrane, etc.)
- Title & abstract screening
- Full-text article selection
- Structured article list (Excel format)
State of the Art (SoTA) Analysis
Definition of current clinical practice and benchmark technologies
Scope: Clinical guidelines, alternative treatments, comparable devices
Delivery: 5–7 business days
What you will receive:
- State of the art analysis
- Identification of alternative treatment options
- Benchmark comparison with existing technologies
- Clinical practice overview
NB-Ready CER Express Review
Independent MDR Annex XIV Clinical Evaluation Review
Scope: Clinical Evaluation Report (CER)
Delivery: 5 business days
What you will receive:
• MDR Annex XIV alignment review
• Structured deficiency list
• Risk flag summary
• Submission-readiness commentary
Technical Documentation Compliance Review
Independent Annex II & III Technical File Assessment
Scope:
Full technical documentation review according to MDR Annex II & III.
What you will receive:
- Structured compliance gap analysis
- Risk management documentation assessment (EN ISO 14971 alignment)
- GSPR consistency review (Annex I)
- Classification & rule verification (Annex VIII)
- Structured deficiency list ready for internal correction
- Executive compliance summary
