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WELCOME to the Medical Devices Training Foundation

According to the European Medical Devices Regulations (MDR), a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  1. Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease
  2. Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or disability
  3. Investigation, replacement, or modification of the anatomy or a physiological or pathological process or state
  4. Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations

Additionally, the regulation specifies that medical devices do not achieve their principal intended action by pharmacological, immunological, or metabolic means, although they may be assisted in their function by such means.

Bearing in mind the above information we have compiled a list of Training Courses that are directly or indirectly related to Medical Devices and the Medical Devices Regulations.


Requirements of the Medical Device Regulation for CE Marking

This one-day medical device training outlines the key requirements, concepts and overall process for CE marking under the medical device regulation. It’s suitable for anyone working in regulatory affairs/quality assurance or staff partnering with medical device manufacturers. 

This stage of your learning journey creates a solid base for implementing your own CE marking projects. It provides essential knowledge about EU medical devices and regulatory affairs from all areas of an organization. It also explains the demands that fall on subcontractors, importers and distributors…….
Duration: 1 Day, Venue: Live On-line & Live On-Site – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


Introduction to Medical Device Software

Gain an understanding of the medical device software lifecycle processes, classification rules and development activities to meet regulatory requirements…..
Duration: 1 Day, Venue: Live On-line – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


Technical Documentation for the Medical Device Regulation

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…..
    Duration: 1 Day, Venue: Live On-line – (Also available as an IN-HOUSE COURSE)
    LINK for FULL DETAILS and REGISTRATION

Implementation of Medical Device Regulation for CE Marking

This three-day course from your partner in learning is especially useful for regulatory affairs, quality management and quality assurance professionals who need to implement the medical device regulation (MDR). The MDR training is also designed for people working for organizations that partner with Medical Device manufacturers. 

You will learn all the requirements needed for conformity assessment, how to fulfil technical documents and how to plan post-market activities required by the MDR. By the end of the course you will be able to put all this knowledge into working practice in your organization…..
Duration: 3 Days, Venue: Live On-Line & Live On-Site – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


The hidden stings of the Medical Device Regulation (MDR) – Annex VII

The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.
Learn some key requirements about Annex VII of the MDR and gain a better understanding of why notified bodies may be seen to behave differently and in a much more detailed way than what organisations may have previously experienced.

Duration: 1 Hour, Venue: On-demand elearning
LINK for FULL DETAILS and REGISTRATION


Requirements of the Medical Device Regulation (MDR)

This on-demand course will give you an understanding of the key requirements, which will provide:

  • Essential knowledge to understand Regulatory Affairs of medical devices in the EU, e.g. in the position of top management, or a manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
  • The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer
  • A basis to learn later about implementation of CE marking projects

Duration: 4 Hours, Venue: On-demand elearning
LINK for FULL DETAILS and REGISTRATION


Requirements of the In Vitro Diagnostic Regulation

The In Vitro Diagnostic Regulation details the requirements which manufacturers have to meet to sell In Vitro Diagnostic devices in the European Union.  It replaces the In Vitro Diagnostic Directive. 
This course introduces you to the key requirements of the IVDR. IVDs will now be classified according to their risk using a new rule-based system. The majority of IVDs will be subjected to independent assessment of their conformity to the Regulation by a Notified Body and will require third-party certification for the first time.

Duration: 4.5 Hours, Venue: On-demand elearning
LINK for FULL DETAILS and REGISTRATION


Manufacturing Process Validation for Medical Devices

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.
This course has been designed to give manufacturers an awareness of EU regulatory and quality requirements regarding manufacturing process validation and the nature of ‘special processes’. 

Duration: 1 Day, Venue: Live On-line – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


ISO 14971:2019 Risk Management for Medical Devices

This one-day intensive course helps medical device manufacturers understand the benefits and impact of ISO 14971:2019. It’s ideal for anyone in a quality assurance, regulatory, engineering or manufacturing role. We also recommend a basic knowledge of medical device development, quality assurance and ISO 13485:2016.
Through a mix of practical activities, classroom learning and group discussion, you will learn risk management terminology and the stages of the risk management process. You’ll also be able to identify links between ISO 149721:2019, ISO 13485:2016, MDR 2017/745 and IVDR 2017/746. 

Duration: 1 Day, Venue: Virtual Classroom & On-demand elearning – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


Clinical Evaluation for Medical Devices

This one-day course offers a robust overview of the clinical evaluation process for medical devices against the medical device regulation (MDR – EU 2017/745), MEDDEV 2.7/1 revision 4 and relevant MDCG guidance documents.
Designed for clinical professionals with a base understanding of general safety and performance requirements, this training teaches you how to explain the key principles of clinical evaluation. During this stage of your learning journey, you will gain skills to determine when your device requires clinical investigation and you will leave with a full grasp of the clinical evaluation process. 

Duration: 1 Day, Venue: Live On-line – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


Medical Device Regulation Expert Training Course – Our Complete Package

Course Reference: STU 119
Our compact training on “MDR-Expert” offers you comprehensive training for the implementation of EU Regulation 2017/745 MDR. You will learn about the regulatory requirements of the MDR and understand the changes that your company must cope with in a timely manner. To get started, you will be given an overview of the requirements of the MDR.

Duration: 5 Days, Venue: Virtual Classroom – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


Medical Device Regulation In Detail 

Course Reference: STU 120
All manufacturers of Class I to III medical products must familiarise themselves with the requirements of the Medical Device Regulation (EU) 2017/745 (MDR) as soon as possible. The regulation has far-reaching implications and affects all classes of medical products. Products that are not medical products as such, are regulated by the Medical Device Regulation (MDR).
Among the aspects changed are the classification of products, previous basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems.

Duration: 1 Day, Venue: Virtual Classroom – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


MD-QMS ISO 13485:2016 Lead Auditor Training

Course Reference: STU 121
Achieve an internationally accepted CQI/IRCA (Charted Quality Institute – International Register of Certificated Auditors) registered certificate.
This ISO 13485 Quality Management System Lead Auditor course has been made in-line with international registers and guidelines. It aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against the ISO 13485 standard and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

Duration: 5 Days, Venue: Face to Face – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


Internal Audits for Auditors Training in the Medical Device Industry According to ISO 13485

Course Reference: STU 121
According to ISO 13485:2016, internal audits are mandatory for manufacturers of medical devices. During this training course you will learn about the specifics of ISO 13485:2016 regarding the audit requirements. You will learn how to plan, prepare, conduct and evaluate internal audits according to ISO 19011:2018. By means of practical examples from the medical device industry, you will gain confidence in the execution of audits and will be able to react to different audit situations.

Duration: 2 Days, Venue: Virtual Classroom – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


Introduction & Implementation of ISO 13485

Course Reference: STU 123
We recommend this training if you would like to familiarize yourself with the contents of ISO 13485:2016 and options for its practical implementation. The medical devices standard ISO 13485:2016 has been issued. What are the key changes compared to ISO 13485:2012? What are the requirements for the quality management systems of medical device manufacturers?

Duration: 2 Days, Venue: Virtual Classroom – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION


In-Vitro Diagnostic Devices Regulation Fundamentals

Course Reference: STU 124
You will learn how to make your transition into IVDR less complex and less time-consuming and you will be able to identify the changes introduced by the new regulation and hence appraise processes and structural impacts on your organisation. You will be enabled to develop stratetgies on how to professionally reply to the new requirements.

Duration: 2 Days, Venue: Virtual Classroom – (Also available as an IN-HOUSE COURSE)
LINK for FULL DETAILS and REGISTRATION