Medical Devices Training

Medical DevicesLearn 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. We also offer a wide range of specialist courses.

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.

Not sure which course is for you? We have a range of complimentary webinars to help you decide.




CE Marking Training

Medical Device CE Marking

£1860
+ VAT

3 days classroom based training course

    • The medical devices CE marking course is designed to provide participants with the knowledge to assist their companies in getting products to market efficiently. 
    • You 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.
View details for Medical Device CE Marking

Introduction to CE Marking for the In Vitro Diagnostics Directive

£750
+ VAT

1 days classroom based training course

    • This BSI course has been designed to introduce the In Vitro Diagnostics Directive (IVDD), the types of product covered by the Directive and the regulatory framework required for placing IVD products on the European market. Participants will gain knowledge about the directive and the development of IVD products as well as their on-going maintenance to achieve continued regulatory compliance throughout the lifecycle of the product.
View details for Introduction to CE Marking for the In Vitro Diagnostics Directive

Application of the In Vitro Diagnostics Directive

£1860
+ VAT

3 days classroom based training course

    • Application of the In Vitro Diagnostics Directive course has been designed to enable you to explore the IVD Directive, gain a greater understanding of the requirements and thus enable your IVD devices to be placed on the European market efficiently.You will be able to apply the requirements of the directive to create technical documentation to support the product throughout its lifecycle.
View details for Application of the In Vitro Diagnostics Directive

ISO 13485 training

Introduction to ISO 13485

£600
+ VAT

1 days classroom based training course

    • BSI’s Introduction to: ISO 13485 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 Introduction to ISO 13485

Internal auditor for ISO 13485

£1235
+ VAT

2 days classroom based training course

    • BSI’s Internal Auditor ISO 13485 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. This intensive course teaches the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011. An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. 
    • Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.
View details for Internal auditor for ISO 13485

Lead Auditor for ISO 13485

£3270
+ VAT

5 days classroom based training 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 Lead Auditor for ISO 13485

Specialist Training

Introduction to Risk Management for Medical Devices

£670
+ VAT

1 days classroom based training course

    • This course is designed to provide participants with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms. This 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.
View details for Introduction to Risk Management for Medical Devices

Compiling and Maintaining Technical Files & Design Dossiers

£850
+ VAT

1 days classroom based training course

    • BSI’s Writing Technical Files for Compliant Devices course is designed to support manufactures by confirming current regulatory requirements of technical documentation. The aim of the course is to speed up the certification process and enable manufacturers to sell compliant devices within the European Union.
    • On completion of the 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.
View details for Compiling and Maintaining Technical Files & Design Dossiers

Clinical Evaluation for Medical Devices

£795
+ VAT

1 days classroom based training course

    • BSI’s Clinical Evaluation for Medical Devices course is designed to support manufacturers by confirming the information necessary to demonstrate clinical safety and performance of their product in accordance with the requirements of the European Medical Devices Directive.
    • On completion of training, manufacturers will be able to determine if a clinical trial is required, prepare a clinical evaluation report including literature review and determine requirements for post-market clinical follow-up and post-market surveillance to support continuing compliance.
View details for Clinical Evaluation for Medical Devices

Medical Devices Utilizing Materials of Animal Origin Regulatory Training

 

Contact us for a customized quote

    This one day course has been designed to provide manufacturers with the knowledge and skills to interpret the regulatory requirements related to producing medical devices utilizing materials of animal origin, including those for which a transmissible spongiform encephalopathies (TSE) risk is expected.

    When you attend this course, you will learn how to reduce risks and uncertainty as you progress through the EU regulatory process.

View details for Medical Devices Utilizing Materials of Animal Origin Regulatory Training

Device – Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process

 

Contact us for a customized quote

    • This specialized course has been designed to provide manufacturers with the knowledge and skills to interpret the requirements of the drug consultation process for devices containing ancillary medicinal substances. The course will provide guidance on how to reduce risks and uncertainty in the EU regulatory process.
    • The course focuses on determination of the applicable European legislation for borderline products, and provides insight into further information and guidance related to the distinction between medical devices and medicinal products. and examines devices incorporating derivatives of human blood or plasma.
View details for Device – Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process

Process Validation for the Medical Device Industry

£850
+ VAT

1 days classroom based training course

    • BSI’s Process Validation for the Medical Device Industry course has been designed to help manufacturers gain awareness of quality requirements regarding validation and the nature of “special processes”. Learn the generally accepted principles of validation, and introduce how-to-do methods of installation, operational, and process qualification.
View details for Process Validation for the Medical Device Industry

Post Market Surveillance and Vigilance

£795
+ VAT

1 days classroom based training course

    • Post-market surveillance including clinical follow-up, complaint and vigilance handling, impacts on all aspects of the Quality Management System. Proactive and reactive sources of information are a regulatory requirement to be incorporated in your post-market surveillance procedures applicable to all products. Obtaining the right post-market information will ensure continued compliance with the directives and identify consumer needs enabling continued product development.
    • BSI’s Post-Market Surveillance and Vigilance course is designed to help you identify the requirements of the European Medical Device Directives , standards and guidance documents to enable effective implementation of a post market surveillance system.
View details for Post Market Surveillance and Vigilance