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ISO 13485 Transition Training Course (from ISO 13485:2003 to ISO 13485:2016) > Discover the key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016 and how these may impact your current QMS. View details for ISO 13485 Transition Training Course (from ISO 13485:2003 to ISO 13485:2016) > HK$1500 0.5 day course│ Now available online
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). View details for ISO 13485 Transition and Auditor Refresher (from ISO 13485:2003 to ISO 13485: 2016) > 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”. View details for ISO 13485: 2016 Introduction Training Course > HK$2800 1 day course│ Now available online
Implementing ISO 13485:2016 Training Course > You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification. View details for Implementing ISO 13485:2016 Training Course > HK$5200 2 days course│ Now available online
ISO 13485:2016 Internal Auditor Training Course > This intensive two day course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485 and evaluate the effectiveness of the quality management system in their organization. View details for ISO 13485:2016 Internal Auditor Training Course > HK$5200 2 days course│ Now available online
ISO 13485 - Lead Auditor Training Course (CQI and IRCA Registration No.: A17579) > 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) > 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. View details for ISO 14971:2019 Risk Management for Medical Devices: Requirements Training Course > HK$2800 1 day course│ Now available online
Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness > Obtain in depth knowledge about this new type of audit and how your organization is best prepared to support the completing of requirements within the allotted time. View details for Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness > HK$5200 2 days 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). View details for Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition training course > HK$2800 1 day course│ Now available online
Requirements of the Medical Device Regulation (MDR) Training Course > Learn about the key requirements and concepts under the Medical Devices Regulation (MDR). View details for Requirements of the Medical Device Regulation (MDR) Training Course > 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. View details for Implementation of Medical Device Regulation (MDR) for CE Marking Training Course > HK$6800 3 days course│ Now available online
IVD Directive to IVD Regulation Transition training course > Our one day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR). View details for IVD Directive to IVD Regulation Transition training course > HK$2800 1 day 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. View details for Requirements of the In Vitro Diagnostic Regulation > HK$2800 1 day course│ Now available online
Implementation of the In Vitro Diagnostic Device Regulation (IVDR) for CE marking > This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business. View details for Implementation of the In Vitro Diagnostic Device Regulation (IVDR) for CE marking > HK$6800 3 days course│ Now available online
Medical Devices – Quality Management Systems Clause by Clause (ISO 13485:2016) > This two day course has been designed to provide an in depth understanding of ISO 13485:2016. View details for Medical Devices – Quality Management Systems Clause by Clause (ISO 13485:2016) > HK$5100 2 days course│ Now available online
Supplier Management for Medical Devices Course > This course will teach medical device supplier the basics of management, which helps their company to establish a reasonable and efficient supplier management system. The course will be conducted in Chinese only. View details for Supplier Management for Medical Devices Course > HK$5100 2 days course│ Now available online
Packaging of Medical Devices > You will learn the basic knowledge and regulatory requirements of medical device packaging. The course will be conducted in Chinese only. View details for Packaging of Medical Devices > 2 days course│ Now available online
CAPA Medical Device > Medical devices and related companies will learn the corrective and preventive measures, and how to apply it to risk management. The course will be conducted in Chinese only. View details for CAPA Medical Device > HK$5100 2 days course│ Now available online
ISO 11137: 2013-1 & ISO 11137-2: 2013 Radiation Sterilization for Medical Devices Training Course > This two day course has been designed to provide an in depth understanding of ISO 11137-1:2013 & ISO 11137-2:2013. The course will be conducted in Chinese only. View details for ISO 11137: 2013-1 & ISO 11137-2: 2013 Radiation Sterilization for Medical Devices Training Course > HK$5100 2 days course│ Now available online
ISO 11135: 2014 Ethylene Oxide Sterilization for Medical Devices Training Course > This two day course has been designed to provide an in depth understanding of ISO 11135: 2014. The course will be conducted in Chinese only. View details for ISO 11135: 2014 Ethylene Oxide Sterilization for Medical Devices Training Course > HK$5100 2 days course│ Now available online
Process Validation Engineer Training Course > The course will be conducted in Chinese only. View details for Process Validation Engineer Training Course > HK$6400 2 days course│ Now available online
FDA 820 Quality System Regulation (QSR) Training Course > The course will be conducted in Chinese only. View details for FDA 820 Quality System Regulation (QSR) Training Course > HK$6500 2 days course│ Now available online
Clinical Evaluation for Medical Devices > This one-day intensive course enables you to gain a detailed understanding of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents View details for Clinical Evaluation for Medical Devices > HK$6300 1 day course│ Now available online