EMC Resources

Introduction to CE and UKCA Marking – Practical Guide

Our CE & UKCA Marking training course provides a practical approach to what you need to know to place your products on the market and into service. The course covers the principles of CE & UKCA Marking for all fields, drawing on examples from our knowledge and experience with consumer products, children’s products, electrical goods, and electronics.

Duration: 1 Day, Venue: Virtual Classroom
LINK for FULL DETAILS and REGISTRATION

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Introduction to CE and UKCA Marking your products. (Ref CON101)

Whether you are an importer, manufacturer, designer or manager, you need to know the basics of CE marking.
This course will guide you through the complete CE marking process, from design considerations and finding the right standards to completing all the necessary documentation

Duration: 1 Day, Venue: On-line or Nr. Buxton Derbyshire, UK
LINK for FULL DETAILS and REGISTRATION

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CE and UKCA Marking Electrical Equipment (Ref CON102)

There are a variety of directives and regulations relating to electrical and electronic equipment, which you should be familiar with if you are involved in the manufacture or importation of such products.
This course will explain who is responsible for CE marking, and what should be done to carry out the process correctly, as well as looking into the directives and standards involved.

Duration: 1 Day, Venue: On-line or Nr. Buxton Derbyshire, UK
LINK for FULL DETAILS and REGISTRATION

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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
LINK for FULL DETAILS and REGISTRATION

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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
LINK for FULL DETAILS and REGISTRATION

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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
  LINK for FULL DETAILS and REGISTRATION

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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
LINK for FULL DETAILS and REGISTRATION

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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

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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

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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

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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
LINK for FULL DETAILS and REGISTRATION

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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
LINK for FULL DETAILS and REGISTRATION

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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
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CE and UKCA Marking Machinery and Industrial Equipment (Ref CON103)

The safety of machinery and industrial equipment is a crucial issue for end-users, but it is not always clear where the responsibility for this lies.
You will gain an understanding of how to carry out assessments on your machinery, including applying the relevant standards and producing and compiling the appropriate documentation.

Duration: 1 Day, Venue: On-line only.
LINK for FULL DETAILS and REGISTRATION

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Machinery Risk Assessment (Ref CON104)

Risk assessments need to be carried out when machines are designed, manufactured, put into service and modified.
This course explains the role of standards in the risk assessment process, to enable designers and project managers to carry out the risk assessment in the most efficient way.

Duration: 1 Day, Venue: On-line only.
LINK for FULL DETAILS and REGISTRATION

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The Pressure Equipment Directive (Ref CON105)

The Pressure Equipment Directive covers all pressure vessels, piping safety accessories and pressure accessories; and it is vital that these products are correctly CE marked.
You will learn who should take responsibility, how to find and apply standards, what documentation you need to produce, and the role of Notified Bodies.

Duration: 1 Day, Venue: On-line only.
LINK for FULL DETAILS and REGISTRATION

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ATEX Compliance and Risk Assessment (Ref CON106)

The ATEX Directive applies to mechanical or electrical equipment used in explosive or potentially explosive atmospheres.
It is very important that this type of equipment is safe to use, and this in-depth course will take you through the CE and Ex marking process in detail. You will gain an understanding of the requirements, including the various options for ensuring equipment is safe.

Duration: 1 Day, Venue: On-line only.
LINK for FULL DETAILS and REGISTRATION

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