The Management System EN ISO 13485:2016 defines quality management system standards for companies involved in one- or more stages of the medical device product cycle.

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The general awareness training for radiological and nuclear issues provides relevant information for all personnel involved with ionizing radiation in a condensed form.

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The awareness training in radiological and nuclear issues for decision makers provides relevant information for the mid-to-senior management level responsible for work in radiation areas.

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The basic course radiation safety and protection provides comprehensive information for all personnel involved with ionizing radiation, as well as supporting and supervising staff.

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The personal radiation detection course provides comprehensive knowledge to work safely and securely in radiation areas under given instructions.

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A table top exercise is an excellent tool to verify concepts and procedures established previously, either theoretically in training modules or in the context of specific applications in a simulated environment.

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Field exercises are an excellent tool to verify concepts and procedures established reviously in a near-realistic environment.

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Manufacturers of equipment (measuring devices or PPE) have the opportunity to test the performance of their products under jointly agreed conditions with live cources, contamination or gaseous radioactive agents.

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Quality Management Systems (QMS) constitute to the production of medical devices, but are also very important in services like commerce or outsourced (sub-)productions. Admission requirements for medical devices use the guidelines of the EN ISO 13485 standard and this seminar focuses on the specific aspects for medical products.

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