DOXPUB 09-0178-SOP

Summary:

Describes a procedure to be followed in case a complaint may be a reportable event according to Customer complaint procedure. Explains how to make the decision on whether to report the event and to which Competent Authority. Applicable to CE marked medical devices which are placed on the market or put into service in Europe under the provisions described in the Medical Device directive (93/42/EEC). Covers decision process, initial reporting, investigation, final reporting and decision criteria.

Included Sections:

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

Included Attachments/Appendices:

Procedural Flow Chart, Initial Incident Report Form, Final Report Form

About This Document:

This is not a generic template, it's a 11-page procedure that was actually created and used in the Regulatory Affairs 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:

• Regulatory Affairs Managers
• Management Representatives
• Executive Management