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ISO 13485 and FDA QSR (21CFR-820) Compliant Products

These products help you meet ISO 13485 and FDA QSR requirements. They are the perfect solution to create an ISO 13485/FDA QSR compliant QMS from scratch or upgrade your existing ISO 13485 QMS to become FDA QSR compliant.

*If you already have implemented ISO 13485 and want to upgrade to 13485 & FDA these are the items you'll need

ISO 13485 /FDA Value Packages
ISO 13485 and FDA Products	Price Each	13485 and FDA QMS	Small Biz Package	All In One Package
ISO 13485 and FDA Quality Manual
ISO 13485 and FDA Compliant QMS Procedures
ISO 13485 to FDA Upgrade Instructions	$199
ISO 13485 and FDA Compliant QMS Forms
ISO 13485:2003 and FDA Compliant Gap Analysis Checklist
ISO 13485 Online Employee Training	$200 (20) $400 (50)		(20 sessions)	(50 sessions)
Introduction to ISO 13485 Presentation
ISO 13485 and FDA Compliant Internal Audit Checklist
ISO 13485 Internal Auditor Training
Set of 11 Employee Flyers
Risk Management Guide
Total Value :		$696	$1135	$1934
Package Discount		-$299	-$438	-$937
Your Price:		$397	$697	$997

UPGRADE to your QMS to FDA QSR compliance from ISO 13485 with these helpful products:

ISO 13485 and FDA Compliant QMS Upgrade Package - includes the additional required procedures and step by step QMS instructions to help your ISO 13485 meet the FDA QSR

ISO 13485:2003 and FDA Compliant Gap Analysis Checklist - FDA Requirements are highlighted for easy differentiation

ISO 13485 and FDA Compliant Internal Audit Checklist - FDA Requirements are highlighted for easy differentiation