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.
The general awareness training for radiological and nuclear issues provides relevant information for all personnel involved with ionizing radiation in a condensed form.
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.
The basic course radiation safety and protection provides comprehensive information for all personnel involved with ionizing radiation, as well as supporting and supervising staff.
The personal radiation detection course provides comprehensive knowledge to work safely and securely in radiation areas under given instructions.
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.
Field exercises are an excellent tool to verify concepts and procedures established reviously in a near-realistic environment.
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.
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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