This course gives students a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485.
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This course is designed to provide participants with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms.
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BSI’s “Medical Devices CE Marking” course is designed to provide students with the knowledge to assist their companies in getting products to market more quickly. Internal and external auditors and management personnel responsible for quality systems for medical device manufacturers will benefit from this course.
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This course is designed to provide students with the knowledge to assist their companies in getting products to market more quickly.
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BSI’s “Overview of ISO 13485:2003, the Canadian Medical Devices Regulations, the European Medical Device Directives, and the Japanese Pharmaceutical Affairs Law” course is designed to provide students with the knowledge to assist their companies in getting products to market more quickly in the Canadian, European, and Japanese markets. Personnel responsible for quality systems for medical device manufacturers will benefit from this overview course which compares the management systems of these foreign regulations with the requirements of the quality management system outlined in ISO 13485:2003.
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BSI’s “Implementing ISO 13485:2003” course introduces the concepts needed to understand, develop, and implement a quality management system as outlined in the medical devices standard ISO 13485:2003. This course also discusses the use of ISO 14971:2007, which contains key principles and guidance for risk management. PD CEN ISO/TR 14969:2005, “Medical devices – quality management systems – guidance on the application of ISO 13485:2003” will also be used as a learning tool.
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BSI’s “ISO 13485:2003 Requirements” competency-based 2-day course teaches a general understanding of the concepts of the ISO 13485:2003 standard and how the requirements impact the day-to-day operations of organizations in the Medical Device industry. An experienced instructor explains the clauses of ISO 13485:2003 in detail, providing a base for understanding the Medical Device Principles and includes auditing the requirements of the standard. Students learn by participating in group exercises and in-depth discussions.
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BSI’s “ISO 13485:2003 Internal Quality Systems Auditor” course, designed for those with knowledge of medical device manufacturing, starts with one full day of review of ISO 13485:2003. Students gain a broad understanding of the ISO 13485:2003 quality management system requirements. In addition, the concepts of ISO 14971:2007, “Application of Risk Management to Medical Devices,” are introduced.
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BSI’s “ISO 9001 Lead Auditor Course with Emphasis on ISO 13485:2003” course begins with a review of ISO 13485:2003 and 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 14971:2007, “Application of Risk Management to Medical Devices,” are introduced.
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Essentials of ISO 13485:2003 eLearning course provides a comprehensive introduction to this standard.
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BSI's "Recorded Webinar - Overview of CE Marking" gives students a broad understanding of the requirements of the Medical Device Directive and the CE Marking approach.
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BSI’s “Overview of CMDCAS Webinar” provides information on the guidelines of the Canadian Medical Devices Conformity Assessment System (CMDCAS). An experienced instructor will lead participants through exercises and discussion points, and participants are encouraged to ask specific questions during the webinar.
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BSI's "Overview of Animal Tissue Requirements" provides participants with a general consideration for the use of animal tissues in the manufacture of medical devices.
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BSI’s “Japan – New Regulations for Medical Devices Manufacturers” webinar provides participants with the vital information they need to place products on the world's second-largest medical device market.
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BSI’s “Japan – New Regulations for Medical Devices Manufacturers” webinar provides participants with the vital information they need to place products on the world's second-largest medical device market.
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BSI's "Recorded Webinar - Overview of ISO 14971:2007" provides information on the impact that ISO 14971:2007 has on the decision making process of a medical device manufacturer who is registered or soon to be registered to ISO 13485:2003.
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