ISO 13485:2003 Express helps you jump-start your ISO 13485:2003 compliance initiative.

With ISO 13485:2003 Express you can easily assess your current environment, automatically analyze it for compliance with the ISO 13485:2003 specification, and quickly generate a customized, actionable plan for bringing your current environment into compliance.

ISO 13485:2003 Express provides a user-friendly, web-hosted environment which you can use effectively, regardless of the depth of your ISO 13485:2003 knowledge. It includes a comprehensive, dynamically driven questionnaire covering all requirements of the standard. The questionnaire is thoroughly annotated with links to glossaries, specifications, and help files to help you come up to speed on the ISO 13485:2003 standard rapidly. Once you have answered the questionnaire, you can perform gap analysis at the press of a button. ISO 13485:2003 Express compares your environment against its ISO 13485:2003 knowledgebase, detailing the gaps which exist in your environment and generating a customized, actionable plan for achieving compliance.

ISO 13485:2003 Express significantly reduces your ISO learning curve, enables you to leverage your existing processes to achieve compliance, and reduces your time-to-certification. After certification, you can use ISO 13485:2003 Express to perform efficient and detailed self-audits to ensure that your environment remains compliant.

To learn more about ISO 13485:2003 Express, download our datasheet.

ISO 13485:2003 Express datasheet