Regulated PM Compliance Checklist

End-to-end compliance checklist for product managers in regulated environments. Covers design controls, risk management, change control, CAPA, software lifecycle, and audit readiness. Cross-referenced across FDA, ISO, and AS9100 so you can satisfy multiple frameworks without duplicating work.

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What’s Inside

Design Controls (FDA 820.30)

All 9 design control elements — planning, input, output, review, verification, validation, transfer, changes.

Risk Management (ISO 14971)

Hazard identification, estimation, evaluation, control measures, residual risk — integrated into development lifecycle.

Software Lifecycle (IEC 62304)

Planning, requirements, architecture, design, testing, maintenance — all three software safety classes.

Change Control

Change request, impact assessment, validation scope, approval workflow, post-change monitoring.

CAPA (FDA 820.100 / ISO 13485)

Non-conformance identification, root cause analysis, corrective action, effectiveness check, closure.

Supplier & Vendor Controls

Qualification, approved vendor list, incoming inspection, supplier audits, performance monitoring.

Audit Readiness

Documentation completeness, traceability matrix, design history file readiness, FDA inspector focus areas.

Cross-Reference Map

Matrix showing where FDA 820, ISO 13485, and AS9100 overlap — satisfy multiple frameworks without duplicating work.

How to Use It

Identify applicable frameworks

FDA 820.30 for US medical devices. ISO 13485 for international. AS9100 for aerospace. IEC 62304 for software. Use the cross-reference map.

Work through each section honestly

Mark Compliant / Partial / Non-Compliant / N/A. Rate current state, not aspirational state.

Build your gap list from Partial / Non-Compliant items

These become your compliance project backlog, ranked by audit risk and remediation effort.

Assign named owners and target dates

Individual accountability — not team ownership — drives closure in regulated environments.

Re-run before major milestones or audits

Treat this as a living document. Re-assess quarterly or before design freeze, submission, or audit.

Regulated PM Compliance Checklist

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Shashikant Pradhan

Senior PM · MES & IIoT Consultant · Author, The Technical Floor · MDEC Systems

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