DOXPUB 12-0050-SOP

Summary:

Describes the design control process used at for the development of all products for commercial distribution. Intended to provide a common language and define the milestones that are critical. Applicable to new products or any changes to current products that may affect the safety, efficacy, or conformance with the Essential Requirements, will be developed using this system. Covers preliminary review, feasibility, development, clinical trails and submissions, and product launch. Includes provisions for compliance with 21 CFR Part 820, ISO 9001, EN 46001, and EN 724.

Included Sections:

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

Included Attachments/Appendices:

Project Concept Worksheet, Project Definition Worksheet

About This Document:

This is not a generic template, it's a 8-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