DOXPUB 09-0220-SOP

Summary:

Provides a procedure for labeling medical devices with the CE marking. Applicable to all medical devices placed by on the market or put into service within the Eurpean Economic Area (EEA) or wherever the MDD is applicable. Covers environmental conditions, declaration of conformity, notified body, and document control.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

List of CE Marked Products

About This Document:

This is not a generic template, it's a 3-page procedure that was actually created and used in the Device Engineering operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Engineering Managers
• Quality Assurance Managers
• Engineering Development & Manufacturing Personnel