Built to the ISO 14155:2020 clause structure, with integrated cross-references to FDA IDE requirements and EU MDR obligations: ISO 14155:2020, ISO 13485:2016, ISO 14971:2019, ICH E6(R3), 21 CFR 812, 21 CFR 50 & 56, and EU MDR 2017/745 Annex XV Chapter II. 100+ audit criteria across seven major audit sections.
What the Checklist Covers
Seven audit sections map directly to the ISO 14155:2020 clause structure.
- Good Clinical Practices & Ethical Principles. Declaration of Helsinki compliance, informed consent (including 21 CFR 50), data privacy, EC/IRB oversight, and 21 CFR 56 IRB requirements. Clauses 4–5.
- Clinical Investigation Planning. CIP development, a dedicated statistical analysis plan section (analysis populations, interim analyses, multiplicity), amendment controls, EU MDR Article 70 substantial modifications, and the Investigator's Brochure. Clauses 6–7, 12; Art. 70.
- Sponsor & Investigator Responsibilities. Device accountability (labeling, storage, expiry, destruction, recall), site qualification, contracts, investigator conduct, and FDA IDE obligations (21 CFR 812.40, 812.110). Clauses 8–9, 15.
- Regulatory Submissions. IDE application content (812.25), EU MDR Annex XV Chapter II documentation, ongoing compliance, premature termination, and clinical investigation reports. Clauses 10–11.
- Monitoring & Data Integrity. Risk-based monitoring strategy with key risk indicators, centralized monitoring, initiation/routine/close-out visits, source data verification, EDC validation, and data management per 21 CFR Part 11. Clause 8.5, 14; ICH E6(R3); 812.46.
- Safety Reporting & Vigilance. Mapped to Clause 19: the full AE/SAE/SADE/USADE/device deficiency classification hierarchy, reporting timelines, periodic safety reports, EU vigilance, and FDA IDE reporting. Clause 19; Art. 80; 812.150.
- QMS Integration. Clinical to CER to PMS feedback loop (Annex XIV, Articles 82–83), design validation linkage (ISO 13485 §7.3.6), TMF archiving (Clause 16), clinical QA auditing, and CRO management.
Key Features
- Corrected clause mapping. Safety reporting is mapped to ISO 14155 Clause 19, with Clause 20/11 correctly addressing final reports and premature termination, and investigation-specific periodic safety reporting terminology rather than PSUR language.
- Safety event definitions table. A pre-built reference table with ISO 14155:2020 definitions for AE, SAE, SADE, USADE, and device deficiency, for consistent classification across auditors and auditees.
- Critical nonconformity rating. A rating scale including a Critical NC category for findings with direct subject-safety or data-integrity impact, with a documented escalation logic table.
- Clinical → CER → PMS loop. A dedicated subsection evaluating the feedback from clinical investigation outputs into Clinical Evaluation Reports, PMS plans, and PMCF study design, per EU MDR Annex XIV, Articles 82 and 83.
- Dual-jurisdiction depth. FDA IDE mapping (21 CFR 50, 56, 812.25, 812.40, 812.46, 812.110, 812.150) alongside EU MDR coverage (Art. 62, 70, 77, 80, 82, 83, Annex XV Ch. II) in one integrated tool.
- Statistical governance. A dedicated SAP section covering analysis populations, interim analyses with stopping boundaries, multiplicity adjustments, and biostatistician approval controls.
What You Receive
- Full QMS audit checklist (.docx), with cover page, scope, and applicable standards
- Table of contents with hyperlinked headings
- Audit finding rating scale with Critical NC and escalation logic table
- Safety event definitions reference table (AE / SAE / SADE / USADE / DD)
- Seven detailed audit sections with 100+ criteria, clause references, and evidence/finding columns
- Findings summary table with category counts and section tracking
- Nonconformity detail and CAPA requirements table
- Audit conclusion and approval signature block
- Revision history documenting technical corrections
Who Should Use This
- Sponsors & manufacturers. System-level self-assessment of clinical investigation programs before regulatory inspections or Notified Body audits, and a gap-analysis tool for new clinical programs.
- Clinical QA teams. Independent quality audit of clinical operations, CROs, investigational sites, and data management centers, structured to ISO 14155 §8.7.
- Regulatory affairs professionals. Verification that regulatory submission documentation meets IDE and EU MDR clinical investigation application requirements before filing.
- Consultants & auditors. A ready-to-deploy audit tool for client engagements.
Experience and Methodology
SAQMS services are developed and delivered based on applicable medical-device regulatory requirements, recognized international standards, audit practices, and practical quality-system implementation experience.
Our approach is grounded in:
- ISO 13485 quality management system requirements
- FDA Quality Management System Regulation requirements
- MDSAP audit-model expectations
- EU MDR and applicable conformity-assessment requirements
- ISO 14971 medical-device risk-management principles
- Applicable sterilization, validation, clinical investigation, supplier-control, and post-market requirements
- Risk-based auditing and objective-evidence evaluation
Each engagement is structured around the client's products, processes, intended markets, regulatory obligations, quality-system maturity, and identified compliance risks.
SAQMS provides independent consulting, internal audits, supplier audits, readiness assessments, remediation support, documentation development, and implementation guidance. Services are performed against defined criteria and documented evidence, with findings and recommendations linked to applicable requirements.
SAQMS does not issue accredited certifications, regulatory approvals, or guarantees of audit or submission outcomes. Certification, regulatory decisions, laboratory testing, and conformity-assessment determinations remain the responsibility of the applicable authorized organizations and regulatory authorities.
Our Commitment
SAQMS delivers technically rigorous, objective, and practical support designed to help medical-device organizations:
- Understand applicable requirements
- Identify compliance gaps
- Establish sustainable quality-system controls
- Strengthen audit and inspection readiness
- Improve traceability and objective evidence
- Address root causes and reduce repeat findings
- Support safe and effective medical-device manufacturing and distribution
All services are conducted with appropriate confidentiality, independence, professional judgment, and conflict-of-interest controls.
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Schedule a Consultation →This document is provided for professional reference. Content reflects ISO 14155:2020, EU MDR 2017/745, ICH E6(R3), and 21 CFR 812 as current at the date of publication. Always verify against the latest editions of applicable standards and regulations.