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ISO 13485 and FDA Compliant Certification for Small Business

Our All in One Documentation and Training Package is our most popular
product - for good reason: It gives you all you need to prepare for registration.

But what if you only have 10 people in your company?
Do you plan to hire out your internal audits and don't need training?

Quite often the same people play many roles in the implementation, so some of the training becomes redundant. The smaller business looking for ISO 13485 and FDA compliant certification needs an affordable, streamlined product. We have designed this package with you in mind.

It's small in price but packs a punch!

The ISO 13485 and FDA compliant Small Business Package includes:

	ISO 13485 and FDA compliant 47 page Quality Manual 26 Procedures describing a COMPLETE Quality System to meet ISO 13485 requirements 41 Forms and tables referenced by the Procedures - not random unneeded forms. ISO 13485 to FDA Upgrade Instructions
	ISO 13485/FDA Gap Analysis Checklist - complete toolkit to help you plan your project.
	ISO 13485/FDA Internal Audit Checklist & Toolkit Conduct your own audits
	ISO 13485 Employee Training for 20 people so your entire organization understands ISO 13485 and how it will impact them.
	ISO 13485 Presentation Materials Clause by Clause review of ISO 13485 for groups
	ISO 13485 Step-by-Step Guide PDF
	Document Control PowerPoint
	ISO 13485 Internal Auditing PPT
	Implementing ISO 13485 PowerPoint
	Complete Support throughout your project We don't abandon you after the sale

This is a downloadable product. You also have the option of purchasing the files on CD-Rom.

You can add additional products or training seats at another time, and we'll always let you upgrade for the difference should you need more.