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.



Training courses

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

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).

HK$2500

1 day course│ Now available online

ISO 13485: 2016 Introduction Training Course >

BSI’s “ISO 13485:2016 Introduction” 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”.

HK$2800

1 day course│ Now available online

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

Qualification Available


  • 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.
HK$23800

5 days course

ISO 14971:2019 Risk Management for Medical Devices: Requirements Training Course >

This one-day intensive course enables greater understanding of the impact that ISO 14971:2019 has on the decision-making process when manufacturing medical devices.
It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.

HK$2800

1 day course│ Now available online

Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition training course >

Our one day training course has been designed to introduce medical device manufacturers and other economic operators in the supply chain to the key changes to requirements for CE marking following the publication of the new Medical Devices Regulation (MDR).

HK$2800

1 day course│ Now available online

Implementation of Medical Device Regulation (MDR) for CE Marking Training Course >

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.

The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.

HK$6800

3 days course│ Now available online

Requirements of the In Vitro Diagnostic Regulation >

This course introduces you to the key requirements of the IVDR. IVDs will now be classified according to their risk using a new rule-based system. The majority of IVDs will be subjected to independent assessment of their conformity to the Regulation by a Notified Body and will require third-party certification for the first time.

HK$2800

1 day course│ Now available online