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.

Onsite Training Public Training eLearning

Understanding and implementing courses

ISO 13485:2003 Requirements (TPECS)

Onsite Training Public Training 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.

Understanding ISO 13485:2003: One day course

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

Implementing ISO 13485:2003: Two day course

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

Understanding ISO 14971:2007: One day course

Onsite Training Public Training 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.

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

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

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

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

Understanding Medical Devices Design Controls: Two day course

Onsite Training This 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 two-day training course helps medical device professionals gain an understanding of how ISO 13485:2003 can improve their business and design control efforts.

ISO 13485:2003 Internal Auditor (TPECS)

Onsite Training Public Training BSI’s “ISO 13485:2003 Internal Auditor” competency-based 3-day course teaches a general understanding of the concepts of the ISO 13485:2003 standard and the principles and practices of effective internal audits in accordance with ISO 19011.

ISO 13485:2003 Lead Auditor (TPECS)

Onsite Training Public Training BSI’s “ISO 13485:2003 Lead Auditor” competency-based 4-day course teaches a general understanding of the concepts of the ISO 13485:2003 standard and the principles and practices of leading management systems and process audits in accordance with ISO 19011.

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

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

Essentials of ISO 13485:2003 - One Hour

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

Overview of CMDCAS: Recorded webinar - Two hours

Onsite Training eLearning Training 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

eLearning Training 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

eLearning Training 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

eLearning Training 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

eLearning Training 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

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

European Medical Devices Directive Requirements

Onsite Training This 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.

Medical Devices CE Marking: Three day course

Onsite Training Public Training This course is designed to provide students with the knowledge to assist their companies in getting products to market faster.

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

Onsite Training Public Training 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.

Medical Devices Risk Management: ISO 14971

Onsite Training 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. This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485:2003.

ISO 13485:2003 Management briefing: One day course

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