Easy to understand and audit-tested documents that you can use as templates, inserting your own processes and requirements.

• Each template has text for you to bend and shape to your particular needs and marketplace.
• Includes a discussion of the text to give you insight into how it should be used, what benefits you can enjoy and more importantly, what pitfalls you should avoid!
• The last column outlines the objective evidence you should be able to produce for a Quality System Auditor or Regulation Inspector.

Each document can be delivered to you electronically at the
prices noted below.  (All prices in US funds)

All documents come in downloadable .pdf format. 

Here is a FREE Sample Document: 

Regulatory Requirements Quality System Procedure
In Vitro Diagnostic Devices (IVDD)

Please select a document below, pay for your purchase and your document(s) will be emailed to you.

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QUALITY MANUALS
ISO 9000:2000 (no medical device requirements)		$199
EN/ISO 13485:2003 for CE Marking		$299
CAN/CSA ISO 13485:2003 for Canadian Medical Device Regulations (CMDR)		$299
Combined EU/CMDR		$399
QUALITY SYSTEM PROCEDURES/TECHNICAL DOCUMENTATION
Management Commitment		$199
Internal Audit		$199
Post Market Surveillance		$199
Approved Suppliers		$99
Device Master Records		$299
Device History Files		$299
Technical Files		$399
Design (Medical Device with EU, CMDR and USFDA Requirements)		$399
Risk Management		$399
Software Verification, Validation and Testing		$799
Vigilance		$99
Process Based Internal Audits		$199
Document Control		$99
Quality Records		$99
Human Resources		$99
Nonconforming Product		$199
Product Realization		$299
Mandatory Device Reporting		$199
Recalls/Field Corrections		$199
Quality Plans		$99
Quality Objectives		$99
Management Analysis and Improvement		$99
Safety and Effectiveness checklists		$99
Essential Requirement Checklists		$99
Correction and Preventative Actions		$299
USFDA Inspections		$199
Please proceed to checkout.  Your files will be emailed to you in .pdf format within 48 hours.