Training course for Medical Device/Medtech

Discover the key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016 and how these may impact your current QMS.

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).

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 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. 

• 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.

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.

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 two day course has been designed to provide an in depth understanding of ISO 13485:2016.

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