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ISO 13485 Medical Devices Training

BSI offers a complete range of Medical device classes. Please select a course below to see more details and view the course schedule.

Awareness courses

Understanding ISO 13485:2003: One day course

This course gives students a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485.

Understanding ISO 14971:2007: One day course

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.

Post Market Surveillance and Vigilance

This course is designed to help you identify the requirements of the European medical device directives (90/385/EEC, 93/42/EEC,98/79/EC), standards and guidance documents to enable effective implantation of a post market surveillance system.

Medical Devices CE Marking

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.

European Medical Devices Directive and 2007/47 Changes Overview

This course is designed to provide students with the knowledge to assist their companies in getting products to market more quickly.

Overview of ISO 13485:2003, the CMDRs, the MDD, and JPAL

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.

Understanding the Japanese medical device market and Pharmaceutical Affairs Law (PAL): One day course

This course provides participants with the vital information they need to open their businesses to the world's second-largest medical market.

Implementing ISO 13485:2003

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.

ISO 13485:2003 Internal Quality Systems Auditor

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.

ISO 9001 Lead Auditor Course with Emphasis on ISO 13485:2003

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.

Overview of CMDR and CMDCAS (Recorded Webinar)

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.

Japan - New regulations for Medical Devices Manufacturers (Webinar)

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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