Training course for Medical Device/Medtech

Learn how to design and develop medical devices to international quality standards such as ISO 13485, how to meet and keep ahead of medical device directive regulatory requirements, and gain knowledge of the CE Marking process. Our expert tutors are industry-leaders who have trained over 70% of the top 100 medical device companies globally, so you know you’ll be learning from the best.

ISO 13485 Transition and Auditor Refresher (from ISO 13485:2003 to ISO 13485: 2016)

HK$2500

1 day course

    With greater attention on the organization’s ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management.

    Discover the latest requirements and explore the changes since ISO 13485:2003 and EN 13485:2012. You’ll refresh your auditing techniques and be able to identify the gaps in your current Quality Management System (QMS).

View details for ISO 13485 Transition and Auditor Refresher (from ISO 13485:2003 to ISO 13485: 2016)

ISO 13485: 2016 Requirements Training Course

HK$2400

1 day course

    BSI’s “ISO 13485:2016 Requirement” one day course has been designed to provide an insight in to the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers.

    Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001 and the FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971, “Application of Risk Management to Medical Devices”.

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ISO 13485 - Lead Auditor Training Course (CQI and IRCA Registration No.: A17579)

HK$21000

5 days course

    • BSI's Lead Auditor ISO 13485 course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, " Guidelines for Quality and /or Environmental Management Systems Auditing." Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results.
    • Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.
View details for ISO 13485 - Lead Auditor Training Course (CQI and IRCA Registration No.: A17579)

Creating and Maintaining Compliant Technical Files and Design Dossiers

HK$2400

1 day

    BSI’s Creating and Maintaining Technical Files and Design Dossiers one day course is designed to support manufactures by confirming current regulatory requirements of technical documentation. The aim of the course is to speed the Notified Body certification process and enable manufacturers to sell compliant devices within the European Union. On completion of training you will be able to identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers.

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Introduction to Risk Management for Medical Devices

HK$2400

1 day course

    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. The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their organizations. 

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Medical Devices CE Marking

HK$6800

3 days

    BSI's Medical Devices CE Marking” three day course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly. Management personnel responsible for all aspects of CE marking medical devices as well as internal and external auditors will benefit from this course. Participants will gain knowledge of the requirements of the Medical Device Directive and the CE Marking approach. Participants will be able to provide leadership for their organizations when placing medical devices on the market in the European Union

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