Training course for Medical Device/Medtech

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”.

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.

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.

This one-day intensive course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe. The aim of the course is to enable manufacturers to:

- Create robust technical documentation to demonstrate compliance to the MDR

- Better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process

This one-day intensive course enables manufacturers to learn about the key requirements, concepts and the overall process for post-market surveillance and vigilance under the MDR and IVDR.

BSI’s ‘Post-market Surveillance and Vigilance under the Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Devices Regulation (IVDR)’ one-day training course has been designed to provide manufacturers with the tools to implement an appropriate system for gaining and reviewing experience in the post production phase from the range of devices they manufacture.

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. 

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).

Learn about the key requirements and concepts under the Medical Devices Regulation (MDR). 

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.

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).

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.

This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.

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. 

You will learn the basic knowledge and regulatory requirements of medical device packaging.

The course will be conducted in Chinese only.

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.

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.

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.

The course will be conducted in Chinese only.

The course will be conducted in Chinese only.

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

This two day training course will give you a good understanding of the FDA 21 CFR 820, Quality System Regulation (QSR).