Why 13485 Store?

We save you time and money.

How long would it take you to create hundreds of pages, formatted to comply with ISO 13485?

• A complete quality manual, following the standard
• 27 procedures, all designed to the standard
• 30 forms, professionally prepared for implementation ease
• Smart numbering to enable a document control system.
• Just think about the labor savings alone!
  • 200 pages already typed in the correct format
  • All of these ready for customization to your company.

Compare our product to using a consultant.

Professional Experience

• Thousands of customers since 2001
• We're the original - don't be fooled by poor quality imitations
• These documents were created by quality professionals with years of experience.

This is what we do best -- shouldn't you focus your time on what you do best?

We support our products throughout the project

You do the project yourself, but that doesn't mean you do it alone.

• Quick email support
• Professional phone support
• 24/7 online resources
• 15-day money back guarantee!

Reputation

• Testimonials
• Member SAE, ASQ
• Member of the Better Business Bureau