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Medical devices

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

Understanding and implementing 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.
This course is offered as public and onsite training.

Implementing ISO 13485:2003: Two day course

This course introduces the concepts needed to understand, develop, and implement a quality management system as outlined in the medical devices standard ISO 13485.
This course is offered as public and onsite training.

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.
This course is offered as public and onsite training.

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.
This course is offered as public and onsite training.

ISO 13485:2003 Internal quality systems auditor: Three day course

This course is designed for those with knowledge of medical device manufacturing and starts with one full day of review of ISO 13485.
This course is offered as public and onsite training.

ISO 9001:2000 Lead auditor course with emphasis on ISO 13485:2003: Five day course

This course begins with a review of ISO 13485 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.”
This course is offered as public and onsite training.

Overview of ISO 13485:2003: Webinar - Two hours

This course gives students a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485:2003.

Overview of ISO 14971:2007: Webinar - Two hours

This course provides information on the impact that ISO 14971 has on the decision making process of a medical device manufacturer.

Overview of CE Marking: Webinar - Two hours

This course gives students a broad understanding of the requirements of the Medical Device Directive and the CE Marking approach.

Japan PAL: Webinar - Two hours

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

Overview of Reduction of Hazardous Substances (ROHS) and Waste Electrical and Electronic Equipment (WEEE): Webinar - Two hours

This course provides information on the impact that the ‘Reduction of Hazardous Substances’ and ‘Waste Electrical and Electronic Equipment’ directives have on the decision making process of a medical device manufacturer who sells or are planning to sell Medical Devices into the European Union (EU).

Overview of CMDCAS and CMDR: Webinar - Two hours

This course provides information on the guidelines of the Canadian Medical Devices Conformity Assessment System (CMDCAS).

Overview of CMDCAS: Recorded webinar - Two hours

This course provides information on the guidelines of the Canadian Medical Devices Conformity Assessment System (CMDCAS) and on how it will affect business in Canada.

Japan - New Regulations for Medical Devices Manufacturers: Recorded webinar - Two hours

This course provides participants with the vital information they need to place products on the world's second-largest medical device market.

Overview of CE Marking for medical devices: Recorded webinar - Two hours

This course gives students a broad understanding of the requirements of the Medical Device Directive and the CE Marking approach.

Overview of ISO 13485:2003: Recorded webinar - Two hours

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

Overview of ISO 14971:2007: Recorded webinar - Two hours

This course provides information on the impact that ISO 14971 has on the decision making process of a medical device manufacturer who is registered, or soon to be registered, to ISO 13485.

Overview of animal tissue requirements: Webinar - one hour

The course provides participants with a general consideration for the use of animal tissues in the manufacture of medical devices.

Medical devices CE Marking: Two day course

This course is designed to provide students with the knowledge to assist their companies in getting products to market faster.
This course is offered as public and onsite training.

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

This course is designed to provide students with the knowledge to assist their companies in getting products to market faster in the Canadian, European, and Japanese markets.
This course is offered as public and onsite training.

ISO 13485:2003 Management briefing: One day course

This briefing is designed to provide executives with the information needed to successfully migrate to ISO 13485.
This course is offered as onsite training.

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