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 medical devices 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 medical devices training courses or have it delivered on your premises as an in-company solution.
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BSI’s “Introduction to ISO 13485:2003” one day course has been designed to provide an insight in to the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers.
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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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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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This course is designed to provide participants with an understanding of the impact that ISO 14971:2007 has on the decision making process at medical device manufacturing firms.
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BSI’s “Process validation for the medical device industry” one day course has been designed to help manufacturers gain awareness of quality requirements regarding validation and the nature of “special processes”. Learn the generally accepted principles of validation, and introduce how-to-do methods of Installation, Operational, and Production Qualification.
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Post-market surveillance including clinical follow-up, complaint and vigilance handling, impacts on all aspects of the quality management system.
Proactive and reactive sources of information are a regulatory requirement to be incorporated in your post-market surveillance procedures applicable to all products.
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This one day course has been designed to provide manufacturers with the knowledge and skills to interpret the requirements of the drug consultation process for devices containing ancillary medicinal substances.
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BSI’s “Implementing ISO 13485:2003” two day course has been designed to provide participants with the knowledge and process steps to enable them to effectively Implement a quality management system in line with the requirements for ISO 13485:2003 certification.
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BSI’s “ISO 13485:2003 Internal Auditor” course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485 and evaluate the effectiveness of the quality management system in their organization.
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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 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing.”
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