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 Management Systems Training can provide training to help you implement a successful Medical Devices Management System. Select a link below to find out more.
You can choose whether you would like to attend one of our scheduled public courses or have it delivered on your premises as an in-company solution.
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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Covering the application of Risk Management to Medical Devices, ISO 14791:2005. Assessment of Risk using FMEA, FTA or Hazop techniques.
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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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BSI's ISO 13485:2003 Lead Auditor Training course begins with a review of requirements of ISO 13485:2003. This course then continues to teach the principles of process auditing in accordance with quality management system standards and ISO 19011:2002, "Guidelines for Quality and/or Environmental Management Systems Auditing." In addition, the concepts of ISO/TR 14971:2001, "Application of Risk Management to Medical Devices," are introduced.
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