ISO13485ReviewKit

ISO 13485:2016 Clause 5.6 Medical Device QMS Annual Management Review Generator

🔴 FDA QMSR §820.35 EFFECTIVE FEBRUARY 2, 2026 — ISO 13485 management review alignment is now a US federal requirement. Generate your compliant review package →
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5 Minutes to Audit-Ready

vs. 20-40 hours of manual prep or $4K–$12K RA consultant cost

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FDA QMSR §820.35 Compliant

Feb 2, 2026 crosswalk included — ISO 13485:2016 Clause 5.6 + MDSAP ready

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EU MDR Article 88 Add-On

Optional PMS Summary/PSUR section for Class IIb/III CE-marked devices

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3-Document ZIP Package

Management Review Report + CAPA Register + FDA QMSR Crosswalk

💳 Choose Your Package

Single Report
$149.99
1 management review package. Best for first-time use.
BEST VALUE
3-Report Pack
$399.99
$133/report. Best for consultants with multiple clients.
Annual Renewal
$79.99
Year 2+ returning customers. Same org, new review year.
RA Consultant API
$699/mo
Unlimited reports. White-label. RAPS RAC consultant tier.
🇪🇺 EU MDR Article 88 PMS Summary Add-On

Adds a Post-Market Surveillance Report/PSUR section for Class IIb/III CE-marked devices (Reg. 2017/745 Art. 88). Required for annual PSUR submission to Notified Body.

+ $49.99

📋 Organization & Device Information

🔴 FDA QMSR §820.35 Effective Feb 2, 2026 | ISO 13485:2016 Clause 5.6 | EU MDR 2017/745

📊 Clause 5.6.2 Review Inputs

Internal audits, Notified Body surveillance, FDA inspection outcomes
Complaint volume, MDR-reportable events, customer satisfaction data
Yield rates, nonconformance rates, OOS results, process KPIs
Open/closed CAPA count, aging, effectiveness verification status
New or updated FDA, EU MDR, Health Canada, ISO requirements affecting your QMS
Field failure rates, MDRs, vigilance reports, PMS/PSUR status, EUDAMED updates

📦 Your Session

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