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About This Item


Full Description


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 project
  • Compare the quality of your documents against your industry peers
  • Learn what other companies in your industry are actually doing

Who Will Benefit:

  • Quality Assurance Managers
  • Manufacturing Managers
  • Regulatory Affiars Managers