Description
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
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 6
- File Size:
- 1 file , 460 KB
