ISO Cloud Consulting
ISO 13485 QMS-in-a-Box — Distributor / Importer
ISO 13485 QMS-in-a-Box — Distributor / Importer
Role-scoped ISO 13485 system for distributors and importers. Excludes non-applicable manufacturing clauses while enforcing post-market, traceability, complaint handling, and regulatory communication controls.
Includes:
• Distributor/importer clause applicability logic
• Mandatory post-market and traceability records
• Audit exposure map for regulatory and complaint controls
• Implementation sequence for non-manufacturers
How to use:
Use clause applicability logic to formally exclude design/manufacturing clauses. Deploy post-market and complaint controls early to prevent major audit findings.
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Why Medical Device Companies Use ISO Cloud Consulting Toolkits
Our toolkits are designed by regulatory professionals who work with:
• ISO 13485 certified manufacturers
• medical device startups
• EU MDR compliance projects
• FDA design control programs
Each toolkit contains practical templates used during real audits.
Built for Real Regulatory Audits
These templates are aligned with:
• ISO 13485:2016
• ISO 14971 risk management
• FDA design control expectations
• EU MDR QMS requirements
Auditors evaluate documented evidence, not theory.
These toolkits give you the exact records auditors expect to see.
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