DOXPUB 12-0065-SOP

Summary:

Describes a procedure for tracking device development projects as they move through five stages from Preliminary Review to Product Launch. Applies to all projects tracked under the design control system. Includes provisions for establishing a deliverables checklist, changing deliverables, handling incomplete deliverables, fulfilling deliverables, completing development stage, defining deliverables, and compliance with ISO 9001.

Included Sections:

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

Included Attachments/Appendices:

Preliminary Review Deliverables Checklist, Feasibility Deliverables Checklist, Development Deliverables Checklist, Clinical Trials Deliverables (Clinical Grade Production), Product Launch Deliverables, Project Stage Transfer Form

About This Document:

This is not a generic template, it's a 14-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