standard published 08/01/2007 by Doxpub, Inc.
Summary:
Provides a procedure for determining and documenting the classification and conformity assessment route of medical devices according to the European Medical Device Directive. Covers preparing a regulatory strategy report, reviewing reports, resolving differences of opinion amongst reviewers and filing final reports. Includes provisions for compliance with MDD 93/42/EEC and 65/65/EEC.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
MDD Regulatory Strategy Report Form
About This Document:
This is not a generic template, it's a 4-page procedure that was actually created and used in the Quality Assurance 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 projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:
Quality Assurance ManagersManufacturing ManagersRegulatory Affiars Managers
