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.

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Understanding and implementing courses

Understanding ISO 13485:2003: One day course

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

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Implementing ISO 13485:2003: Two day course

Onsite TrainingPublic TrainingThis course introduces the concepts needed to understand, develop, and implement a quality management system as outlined in the medical devices standard ISO 13485.

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Understanding ISO 14971:2007: One day course

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

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

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Understanding ISO 13485:2003 and the Quality System Regulations: One day course

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

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Understanding Medical Devices Design Controls: One day course

Onsite TrainingThis course is designed to provide participants with an understanding of the impact that ISO 13485:2003 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 13485:2003 can improve their business and design control efforts.

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Auditor courses

ISO 13485:2003 Internal Quality Systems Auditor

Onsite TrainingPublic TrainingThis course is designed for those with knowledge of medical device manufacturing and starts with one full day of review of ISO 13485.

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ISO 9001:2008 Lead auditor course with emphasis on ISO 13485:2003: Five day course

Onsite TrainingPublic TrainingThis 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.”

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ISO 13485:2003 and the FDA’s Quality System Regulations Internal Quality Systems Auditor: Three day course

Onsite TrainingThis course, designed for those with knowledge of medical device manufacturing, starts with one full day of review of ISO 13485:2003.

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Webinars

Essentials of ISO 13485:2003 - One Hour

eLearningEssentials of ISO 13485:2003 eLearning course provides a comprehensive introduction to this standard.

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Overview of CMDCAS: Recorded webinar - Two hours

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

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

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

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

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

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

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

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

eLearning TrainingThis 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.

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Overview of animal tissue requirements: Webinar - one hour

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

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Other courses

Asia Medical Device Regulatory Update

Onsite TrainingPublic TrainingIn Asia, not understanding or failing to comply with various regulatory requirements can severely inhibit your ability to conduct business.  Conversely, rapid registration and regulatory approval will give you a significant competitive advantage. 

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European Medical Devices Directive Requirements

Onsite TrainingThis course is designed to provide a toplevel overview of the guidelines of the European Medical Device Directives MDD 93/42/EEC and comprehensive information on the MDD 2007/47 changes.

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Medical devices CE Marking: Three day course

Onsite TrainingPublic TrainingThis course is designed to provide students with the knowledge to assist their companies in getting products to market faster.

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

Onsite TrainingPublic TrainingThis 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.

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ISO 13485:2003 Management briefing: One day course

Onsite TrainingPublic TrainingThis briefing is designed to provide executives with the information needed to successfully migrate to ISO 13485.

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