Medical Devices training courses

Medical Devices training courses

Our medical devices courses allow you to have a detailed look at some of the most important sections of bringing a successful product to market within this highly regulated sector.

Our medical devices courses allow you to have a detailed look at some of the most important sections of bringing a successful product to market within this highly regulated sector.

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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

ISO 13485:2016 Clause by Clause >

This two-day course has been designed to provide an in depth understanding of ISO 13485:2016. Learn about the various clauses of the standard and understand the implications behind medical devices quality management. Allow our medical devices experts to guide you in unravelling the standard, and bring Medical Devices Quality Management to your organization.

$2195

2 days classroom-based training course | Now available online

Implementing ISO 13485:2016 >

Our Implementing ISO 13485:2016 two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016 certification.

Contact us for a customized quote | Now available online

Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition >

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).

$1995

1 day classroom-based training course | Now available online

Implementation of Medical Device Regulation for CE Marking >

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.

$3195

3 days classroom-based training course | Now available online

Requirements of the In Vitro Diagnostic Regulation >

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.

$1995

1 day classroom-based training course | Now available online

Implementation of the In Vitro Diagnostic Device Regulation for CE Marking >

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.

$3195

3 day classroom-based training course | Now available online


Auditor courses

ISO 13485:2016 Lead Auditor >

This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results.

$4995

5 days classroom-based training course | Now available online


Risk Management training courses

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


Specialist training courses

Performance Evaluation and Clinical Evidence for In Vitro Diagnostics (IVDs) >

This one-day intensive course enables greater understanding of performance evaluation for In Vitro Diagnostic devices, how performance fits into the product development lifecycle and seeks to prepare for future IVD Regulation (IVDR) requirements for clinical evidence.

Contact us for a customized quote | Now available online

Clinical Evaluation for Medical Devices >

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. 

Contact us for a customized quote | Now available online

Introduction to Risk Management for Medical Devices >

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. 

Contact us for a customized quote | Now available online

Medical Devices CE Marking >

Become confident in understanding the legal and operational aspects of European regulatory and standards principles and ensure your devices quickly meet safety and quality standards. Learn how to identify risks and report product changes to ensure the quality and safety of your products.

Contact us for a customized quote | Now available online