5 Day Medical Device School: From Concept to CE Marking Training Course – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “The Medical Device School – From Concept to CE Marking Training Course” conference has been added to ResearchAndMarkets.com’s offering.

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Bringing a medical device to the marketplace is a complex and lengthy procedure which requires experience, knowledge and specialist skills. The contribution to successful market placement comes from many different skilled individuals and organisations who should be aware of all the stages involved and be able to relate their responsibilities to the needs of other professionals, scientists, clinicians and regulatory and quality experts.

The programme will commence with a general introduction as to what devices are and how they are developed, and continue with lectures, practical workshops and case studies covering each process applicable to device development, marketing and, eventually, postmarket procedures. There will be ample time throughout the five days for informal discussions with our expert faculty and fellow professionals.

Who Should Attend:

This event has been designed primarily for those who wish to understand the processes involved in bringing a medical device to market. General medical devices as well as active implantable, in-vitro diagnostic and drug device products will be covered in the programme.

The course will be of particular interest to those seeking to introduce new medical devices to the market. Previous delegates who have benefited include regulatory, quality, clinical and marketing managers.

Benefits of attending:

Learn what regulations control the manufacture and marketing of devices in the EU

Ensure compliance with the MDR

Gain an insight into different aspects of the process for obtaining the CE mark for a device

Discover a holistic approach to device development and marketing

Participate in workshops and learn from other people’s experiences

Understand how other professionals affect the process for bringing a device to market

Network with participants from organisations similar to your own


Day One

What is a Medical Device?

Definitions and examples

Device Design and Development


Device innovation

How is a device developed from concept?

From idea to market, the overall steps

What Regulations Control the Manufacture and Marketing of Devices in the EU?

A brief history of the Medical Device Directives explained (AIMDD, MDD and IVDD)

An overview of the Medical Device Regulations 2017/745

How Does a Device obtain a CE Mark?

What does the CE Mark mean?

Overview of the CE Mark process for a device

Device classification


Economic Operators, Competent Authorities and Notified Bodies

Who are economic operators and what are their responsibilities?

What is a competent authority?

The role and responsibility of a competent authority

What is a Notified Body?

The role and responsibility of a Notified Body

Relationships with manufacturers

Classification of Medical Devices

How do you classify a medical device?

Classification workshop with case studies

Day Two

Risk Analysis and Risk Management

Review of ISO EN 14971:2007, ‘Medical Devices Application of Risk Management to Medical Devices’

What procedures must a manufacturer follow?

How Should a Risk Analysis be Conducted? – Risk Analysis Workshop

Biological Evaluation of Medical Devices

ISO 10993 and the biological safety assessment process

Where product safety assessment fits in New Product Development

Technical Files and Design Dossiers

What are these documents?

What should they contain and how should they be presented?

Quality Systems for Medical Devices

What is a Quality System?

What do manufacturers need to do to implement a Quality System?

What are the regulations and guidelines for Quality Systems?

Labelling and Packaging of Devices

What information needs to be provided and how should it be set out?

What regulations and guidelines should be followed?

Day Three

Regulations and Guidelines Applicable to Medical Device Studies

Review of ISO 14155 and other available guidelines

Clinical Evaluations

How to conduct clinical evaluations

Controls of the clinical evaluation plan and clinical evaluation report

Literature search

Conducting Medical Device Clinical Investigations

How to conduct medical device clinical investigations

Study design

Study content

Documents Necessary for Medical Device Clinical Investigations

Clinical investigation plan

Clinical investigation report

Clinical Investigation/Evaluation Workshop

Approvals for Conducting Clinical Studies

Documents required

Ethics committees

Competent authorities

Day Four

Software and Medical Devices

Understanding the requirements for medical device software

Software qualification and classification

Clinical evidence for medical device software

Additional considerations for Artificial Intelligence

In-Vitro Diagnostic Products

The IVD Directive

New IVD Regulation (2017/746)

Transition period preparation

Impact on Compliance and risk analysis

Making Sense of the European Reimbursement Environment

Making sense of reimbursement, regulation and market access

Understanding different approaches adopted to the reimbursement of medical devices

Implications for manufacturers of medical devices

Drug/Device Products

Regulations for the demarcation of medicinal products and devices

Exploration of borderline issues

Quality considerations

Devices Incorporating Materials of Animal Origin

What’s the risk?

Specific standards on animal materials

Conformity assessment for devices containing animal-derived materials

Day Five

Post-market surveillance (PMS)

What constitutes PMS? The basic principles

The regulatory requirements for PMS

The increasing importance of PMS

A review of available guidelines for PMS

EC Medical Device Vigilance

Basic principles

Reporting arrangements

Role of the manufacturer, competent authority and Notified Body

Review of the available guidelines for device vigilance

Workshop with case studies

For more information about this conference visit https://www.researchandmarkets.com/r/59q6ry

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.



Laura Wood, Senior Press Manager

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