Training courses for ISO 13485, ISO 14971 and CE Marking

Our ISO 13485, ISO 14971 and CE Marking training will help you demonstrate your ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.

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.

Browse our medical devices training courses to find the right one for you, or call our training advisors to discuss your requirements: 1300 730 134.




Training courses

Learn the basics of the ISO 13485 medical devices standard.


Auditing Skills

Learn how to audit against the standard, and ensure your organization is keeping compliant with the standard.


Risk Management

Effectively manage your medical devices risks with our risk management courses based on ISO 14971.

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

 

1 day In-House training course (contact us for a customized quote)

    Learn about European legislation for borderline products and gain insight into further information and guidance related to the distinction between medical devices and medicinal products. Understand the ancillary medicinal substance consultation process, and find common problems encountered by manufacturers during this process. This course also examines devices incorporating derivatives of human blood or plasma.

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CE Marking

Further your understanding of European directives, and learn the requirements that your medical devices need to abide by.

Introduction to: CE Marking for the In Vitro Diagnosis Directive

 

1 day In-House training course (contact us for a customized quote)

    Gain an introduction to the In Vitro Diagnostics Directive (IVDD) covering its background and key features. Understand the entire audit process so you can go on to develop IVD quality products, meet safety standards, gain EU market access and maintain compliance throughout the lifecycle of your products. 

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Specialist Training

Introduction to Risk Management for Medical Devices

 

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    This in-house training 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. 

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Compiling and Maintaining Technical Files & Design Dossiers

 

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    This one day course is designed to support manufacturers by confirming current regulatory requirements of technical documentation. The aim of the course is to help you better manage the Notified Body certification process and enable manufacturers to sell compliant devices within the European Union. 

    On completion of 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. 

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Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs)

 

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    When placing an IVD device on the European market, you must demonstrate that it complies with necessary regulatory requirements through appropriate conformity assessment procedures. Learn how to plan for appropriate performance studies for your IVD device and gather required information and data needed for a body of clinical evidence under the proposed future IVDR.

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Clinical Evaluation for Medical Devices

 

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    This one day 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. 

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Medical Devices Utilizing Materials of Animal Origin Regulatory Training

 

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    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.

    This course focuses on helping you determine the applicable European legislation and guidance including 93/42/EEC, 90/385/EEC, 722/2012, BS EN ISO 22442 and MedDev 2.11/1.

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

 

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    This one day 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.

    This in-house 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. This course also examines devices incorporating derivatives of human blood or plasma.

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

Medical Device Post Market Surveillance and Vigilance

 

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    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. 

    This one day course is designed to help you identify the requirements of the European medical device directives (90/385/EEC, 93/42/EEC, 98/79/EC), standards and guidance documents to enable effective implementation of a post market surveillance system.

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