Medical Devices training courses

Medical Devices training courses

Learn how to manage quality management for medical devices that meet customer and regulatory requirements.

Learn how to manage quality management for medical devices that meet customer and regulatory requirements.

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Medical Devices 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.




ISO 13485 training courses

Learn the basics of the ISO 13485 medical devices standard.

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 (exc GST) | 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.

2 days classroom based training course (contact us for a quote) | Now available online

CQI and IRCA Certified 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 training course (inc GST) | Now available online


MDSAP training courses


CE Marking training courses

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.

3 days In-House training course (contact us for a customized quote) | 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 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 EU Representative.s

$3195

1 day classroom-based training course | Now available online

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

To help implement the requirements of the European In Vitro Diagnostic Device Regulation (IVDR 2017/746) to obtain and maintain the CE mark for your product. Gain confidence with the IVD classification rules and the conformity assessment routes. Learn the importance of the General Safety and Performance Requirements in product development, and of scientifically robust performance evaluation and clinical evidence.

$3685

3 day classroom-based training course | Now available online


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 >

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.

1 day In-House training course (contact us for a customized quote) | Now available online


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.

1 day classroom-based training course | Now available online