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Implementing the EU Medical Devices Directive 93/42/EEC Stage 8: Compile and validate all appropriate documentation Whilst compliance with the Directive is a mandatory requirement, it should be used as an opportunity to develop a sound quality management system that will offer benefits to your organisation. Develop your documentation in a way that is useful both internally and that can also be readily assessed by your Notified Body. Guidance for the development and documentation of quality manuals is detailed in ISO 10013. Where preferred, the use of checklists and flow charts is strongly supported. Make your system "user friendly". Encourage your workforce to use the system as a daily tool. Before calling on your Notified Body for an assessment, undertake an internal audit yourself and ensure that the system is fully functional and meets the requirements of the Directive. You may consider formal internal assessor training for members of your staff in order to support and maintain the system. Your Notified Body will expect to be able to undertake a desk review of your quality management documentation approximately 4 to 8 weeks prior to your assessment. Whilst ISO 9000 / EN 46000 Standards are comprehensive, they do not cover every aspect of the Directive. Care should therefore be taken to ensure that all aspects of the Directive are considered and acted upon. It should be noted that a 'Design Dossier' is required for Class III devices.
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