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ISO 13485 QMS | CER/CEP Writer | Risk Management | SOP Gap Analysis | EU MDR/IVDR
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ISO 13485 SOP Generator
- ✓ 16 SOPs Available
- ✓ CAPA & Risk Management
- ✓ PMS & Vigilance
- ✓ Clinical Evaluation
GSPR Checklist
- ✓ MDR & IVDR Support
- ✓ Annex I compliance
- ✓ Applicability check
- ✓ Detailed justifications
PRO
CER Writer
- ✓ MEDDEV 2.7/1 Rev 4
- ✓ PubMed literature search
- ✓ 12 structured sections
- ✓ Equivalence analysis
PRO
Complete QMS
- ✓ 80+ QMS documents
- ✓ ISO 13485 clause coverage
- ✓ Cross-referenced docs
- ✓ ZIP package download
PRO
Risk Management
- ✓ ISO 14971 compliant
- ✓ FMEA hazard analysis
- ✓ Risk-benefit analysis
- ✓ Mitigation measures
PRO
Usability File
- ✓ IEC 62366-1 compliant
- ✓ Use specification
- ✓ Formative evaluation
- ✓ Summative testing plan
Standards ID
- ✓ Core standards
- ✓ IEC 62304 software
- ✓ ISO 14971 risk
- ✓ Product-specific
Audit Plan & Report
- ✓ Complete audit plan
- ✓ Audit report generator
- ✓ Findings & deviations
- ✓ Multi-standard support
CER Gap Check
- ✓ Missing sections
- ✓ Traceability gaps
- ✓ MEDDEV/MDCG check
- ✓ Gap analysis table
PRO
CEP Writer
- ✓ MDCG 2020-13 format
- ✓ Literature search strategy
- ✓ Equivalence criteria
- ✓ PMCF planning
PRO
SOP Gap Analyzer
- ✓ Upload existing SOPs
- ✓ ISO 13485 gap analysis
- ✓ Severity classification
- ✓ Remediation priorities
Trusted by Medical Device Professionals
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Active Users
100s
Documents Generated
100%
MDR/IVDR Compliant
ISO 13485
Full Coverage
What Our Users Say
"Generated our complete ISO 13485 QMS in a fraction of the time it would have taken manually. The cross-references between documents are incredibly well done."
Quality Manager
SaMD Startup, Cardiology
EU MDR 2017/745
EU IVDR 2017/746
ISO 13485:2016
FDA 21 CFR 820
ISO 14971:2019
IEC 62304
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Pricing
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- ✓ 1 document
- ✓ 7 basic tools
- ✓ Word download
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€39/mo
€468/year if billed monthly
- ✓ All 12+ tools
- ✓ 10 documents/month
- ✓ 1 Complete QMS/month
- ✓ 1 CER/month
- ✓ Word/Excel/ZIP exports
- ✓ Priority support
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