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 devices
medical devices
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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.

 

Our popular courses


Your training journey

By working closely with you and fully understanding your requirements, we can create a training solution that meets the needs of your organization, whether you're training on existing standards, regulatory approval, or business improvement. We’re one of few certification bodies offering diverse medical device training portfolios consisting of specialized training classes.

We offer a comprehensive range of medical device training courses covering a variety of formats, including public or if you prefer to have a group of employees attend a course together, choose in-house - it's your choice. Courses can be customised to your requirements.


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.

$2295

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

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

Manufacturing Process Validation for Medical Devices: Introduction to Concepts and Methods >

This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices, in line with the European Medical Device Regulations (MDR) and ISO 13485:2016 requirements in Europe. The aim of the course is to enable manufacturers to know what process validation evidence is necessary to demonstrate the manufacturing process is validated.

1 day in-house training course

Technical Documentation for the Medical Device Regulation (MDR) Training Course >

This one-day intensive course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe. The aim of the course is to enable manufacturers to:

  • Create robust technical documentation to demonstrate compliance to the MDR
  • Better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process

1 day in-house training course | Now available online

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