DOXPUB 09-0199-SOP

Summary:

Describes a procedure for creating, maintaining, and archiving of the technical documentation regarding medical devices labeled with the CE marking as required by the Medical Device Directive (MDD) 93/42/EEC. Applicable to all medical devices placed by on the market or put into service by within the European Economic Area (EEA) or wherever the MDD (93/42/EEC) is applicable. Also applies to all medical devices manufactured and/or distributed for use in clinical trials within the EEA or wherever the MDD (93/42/EEC) is applicable.

Included Sections:

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

Included Attachments/Appendices:

Technical Documentation Index, Technical Documentation Approval Form

About This Document:

This is not a generic template, it's a 6-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