You get all of these powerful documents and more in both electronic and hard copy format!
Complete Set ONLY $1489.00

2CheckOut.com Inc. (Ohio, USA) is an authorized retailer for goods and services provided by Certified Compliance Solutions, Inc.

We provide several templates, SOP's and examples for individual sale. The link below will allow you to browse our selection and choose what best suits your needs.

Click Here for Individual Modules and Templates

510(k) Templates and Samples Package

Preparing submissions for the FDA? Need a Technical File for CE Mark? Take the mystery and misery out of compliance submissions. Save hundreds of hours by using the Certified Compliance Solutions 510(k) templates or call the CCS team for help.

Get everything you need in our complete binder and compact disk:

Also Included on the CD: FDA Documents (electronic copy only)

• 21 CFR Part 820: Quality System Regulation (pdf)
• 510(k) Reqenuiremts for Medical Devices (pdf)
• The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications (pdf)
• Design Control Guidance for Medical Manufacturers (pdf)
• Quality Systems Inspection Technique (pdf)
• Device Labeling, Suggested Content (pdf)
• Device Advice – Labeling Requirements (html)
• Do It By Design, An Introduction to Human Factors (pdf)
• General Principles of Software Validation (pdf)
• Glossary of Computerized System and Software Development Terminology (pdf)
• Guidance for the Content of Premarket Submission Containing Software (pdf)
• Guidance for Off-the-Shelf Software Use in Medical Devices (pdf)

The documents provided are samples of the types of specifications that have been submitted under the 510(k) program and received clearance from the FDA. (The sample specifications are not from an actual medical device.)

Major benefits of using CCS 510(k)Templates and Samples:

• Simplify CE Mark audits
• Streamline 510(k) submissions
• Reduce compliance risk
• Save time