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ISO 13485 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?

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

It's small in price but packs a punch!

The Small Business Package includes:

• ISO 13485 Quality Manual
  
  
• 27 Procedures describing Quality System Processes to meet ISO 13485 requirements
  
  
• 30 Forms and tables referenced by the Procedures
  
  
• Gap Analysis Checklist
  
  
• Internal Audit Checklist
  
  
• Online ISO 13485 Training
  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.

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