Six documents for a defensible CER system — procedure, root cause analysis, tracking log, effectiveness verification, trend metrics, and FDA audit prep.
Instant download. For QA managers at FDA-regulated device companies.
FDA QMSR §820.100 and ISO 13485 §8.5 require a documented CER system covering investigation, root cause analysis, corrective and preventive actions, and effectiveness verification. The most common gaps: inadequate root cause investigation, missing effectiveness checks, and trend data not reaching management review.
This toolkit gives you the procedure, the forms, the RCA methods, the effectiveness protocol, and the FDA audit prep guide — everything needed to build a CER system that holds up under inspection.
From problem identification through effectiveness verification and management review reporting.
Complete CEP per EU MDR Article 61 and MEDDEV 2.7.1 Rev 4. Covers clinical evaluation scope, intended purpose, clinical claims, equivalence strategy, literature search methodology, clinical data sources, and acceptance criteria. Designed for CE marking submissions and notified body review.
Fully structured CER template aligned with MEDDEV 2.7.1 Rev 4 requirements. Includes all mandatory sections: device description, clinical background, equivalence assessment, literature data appraisal, clinical investigation data, benefit-risk determination, and conclusions. Pre-formatted for notified body submission.
Reproducible literature search protocol for clinical evaluation. Covers search string development (MeSH terms, Boolean operators), database selection rationale (PubMed, EMBASE, Cochrane), search documentation requirements, and PRISMA flow diagram template. Satisfies MEDDEV 2.7.1 Rev 4 Appendix A methodology requirements.
Structured data appraisal worksheet for literature review and clinical investigation data. Includes methodological quality assessment (study design, bias evaluation, statistical power), clinical relevance scoring, suitability determination, and contribution to clinical evaluation. Aligned with MEDDEV 2.7.1 Rev 4 Appendix A6.
Comprehensive equivalence assessment template covering EU MDR Annex IX requirements. Evaluates technical, biological, and clinical equivalence with side-by-side comparison tables, gap analysis, and justification documentation. Includes guidance on demonstration of equivalence for different device categories.
Post-market clinical follow-up (PMCF) and clinical evaluation update schedule template. Defines update frequency triggers (proactive and reactive), literature surveillance methodology, registry monitoring, complaint data integration, and CER revision workflow. Aligned with EU MDR Article 61 and MDCG 2020-6.
The most common CER failure FDA cites: fixing the symptom without identifying root cause. The RCA toolkit gives you five structured methods to get to the real cause every time.
FDA consistently flags CERs closed without evidence of effectiveness. The effectiveness check protocol tells you exactly how to define, execute, and document a defensible verification.
ISO 13485 and QMSR both require CER trend data at management review. The dashboard template is ready to populate — open/closed, cycle time, recurrence rate, source breakdown.
“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
Joshua Millage, CEO — AB Medical Technologies
“When you've been through enough FDA inspections, you learn what documentation gaps get flagged and which ones slide. These templates close the gaps that matter. We developed them alongside our own QMS buildout and they've held up under audit.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
An immediate correction (or containment) addresses the affected product or process right now — quarantine, rework, withdrawal. A CER addresses root cause to prevent recurrence. FDA QMSR §820.100 requires both: you must correct AND investigate root cause for significant nonconformances. The CER procedure template includes the decision tree for when each is required.
There is no regulatory timeframe — it must be risk-based. The toolkit includes a tiered cycle time framework based on nonconformance severity: critical (30 days), major (60 days), minor (90 days). FDA investigators look for CERs open for an unreasonably long time and CERs closed prematurely without effectiveness verification.
An effectiveness check is objective evidence that the clinical evaluation actually prevented recurrence. FDA QMSR §820.100(a)(7) requires it. Timing depends on the action — typically 30-90 days after implementation. The effectiveness check protocol template covers method selection, success criteria, and documentation.
No. This is a practitioner reference toolkit. Consult your regulatory counsel for formal compliance opinions.
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Six documents. Instant download. FDA QMSR §820.100 + ISO 13485 §8.5.