Effective quality management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. ISO 13485 provides a focus for the quality management system requirements for medical device manufacturers.
BSI can provide training to help you implement a successful Medical Devices Management System. You can choose whether you would like to attend one of our scheduled open courses or have it delivered on your premises as an in-company solution.
BSI’s “Medical Devices CE Marking” 3 day course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly.
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Attend BSI’s “Introduction to CE Marking” 1 day course and start making informed decisions with regard to meeting the requirements of the EU Medical Devices Directives.
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This one day introductory course will give students a broad understanding of the ISO 13485 Quality Management Systems requirements, including the proposed revisions. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be introduced. This course is highly interactive with lively debate and in-class discussion, real life examples, and exercises.
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This seminar offers the opportunity to consider in depth BS EN ISO 13485:2003 and provides specific insight into its application within the medical device field. It adopts a practical approach to implementation at each tier of business processes, and features dedicated discussions of internal and external quality assessment and international regulation issues.
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BSI’s Lead Auditor ISO 13485 course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality and/or Environmental Management Systems Auditing.”
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This course outlines details of ISO 13485:2003 and compares it’s requirements with ISO 9001:2000. Also covers the planning, preparation, conducting, reporting and closure of internal audits.
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