13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification

ISO 13485 and FDA Compliant All in One Certification Package

Everything you need to prepare for ISO 13485 Registration in ONE PACKAGE

Make ISO 13485 registration simple and foolproof! The ISO 13485 All-in-One Certification Package is ideal for organizations who want access to a proven, efficient system with all the necessary elements in place. It has been refined and improved over a ten-year period, and has helped thousands of companies achieve ISO 13485 Registration.
Look at each component - compare us to others!

ONLY (Over $2000 worth of products)

Steps to ISO 13485

Included items to ensure your success:

Learn ISO 13485

"Introduction to ISO 13485" Presentation Materials

Guidance from ISO Experts throughout your project via email or phone

Create a Plan

ISO 13485 and FDA Gap Analysis Checklist

Project Manager's Guide with Timelines & Tools

Get Everybody On Board

"Introduction to ISO 13485" Computer-based training

Can be CUSTOMIZED for your company!

Employee Flyers to inform your organization.

Complete the QMS Documentation

(with professionals to guide you)

QMS Package which includes:

47 page Quality Manual- complete, easy to use, and not excessive
26 Procedures - covering EVERY ISO 13485 requirement - not just a few.
41 QMS pertinent Forms - not random employee forms we had laying around
ISO 13485 to FDA Upgrade Instructions
Hands on support - Our QMS is so easy, you won't have to call. But you can - anytime!

Create a solid Audit Program -
with RAB/QSA Compliant Materials

(Not just a boring PowerPoint...)

ISO 13485 and FDA Internal Audit Checklist Easy to use, easy to customize

Internal Audit Plan and Forms for a complete package

Internal Auditor Training Materials so you can train your internal auditors

Select a Registrar

We can help you interview and select a registrar that fits your organization.

well ALMOST everything...

A copy of the ISO 13485 Standard

Due to copyrighting we are not able to include a copy of the ISO 13485 or 14971 standard, but we provide an easy link for you to buy one from TechStreet

Why aren't ISO Standards free?

Every purchase is backed by our guarantee, and comes with full customer support.

Do you have any questions? Call us toll-free at 1-877-942-6572 or email us.

Why aren't ISO standards free?

Per ISO: ISO standards cost money to develop, publish and distribute. Someone has to pay. The current system whereby users are requested to pay for the standards they use, not only sustains the development process but also, very importantly, ensures that the balance of independent vs. government, private vs. public interests can be maintained.

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