Medical device training courses

We understand the challenges of meeting regulatory requirements and maintaining quality management systems. We understand because it's what we do, every day of every week; for you, for your customers, and for your bottom line.

We have dynamic course owners around the world, allowing delivery of training in many local languages. Our course owners are subject matter experts and use practical examples from their experiences to bring each lesson to life.

 



Introductory, Requirements and Implementing courses

Implementation of Medical Device Regulation for CE Marking

$3185

3 days classroom-based training course

    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 according to their obligations by MDR.

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Requirements of the In Vitro Diagnostic Regulation

$1995

1 day classroom-based training course

    Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period. To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and Representative.

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Implementation of the In Vitro Diagnostic Device Regulation for CE Marking

$3685

3 day classroom-based training course

    Explore the role of risk management during product development and in post market follow up. Develop an understanding of the interface and interaction with Notified Bodies, economic operators (importers, distributors, EU Representatives) and subcontractors/suppliers, according to their obligations under the IVDR.

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Auditor courses



Specialist training courses

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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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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