Introduction to the Medical Device Industry

The course is broadly aimed at employees in the medical device industry who need insight into the industry and an understanding of the methods, relationships, and regulatory requirements that are essential to working in the industry. The course is particularly well suited to providing new employees with a comprehensive overview of the industry.

Who should attend

The course is broadly aimed at employees in the medical device industry who need insight into the industry and an understanding of the methods, relationships, and regulatory requirements that are essential to working in the industry. The course is particularly well suited to providing new employees with a comprehensive overview of the industry.

Content

The course begins with a general introduction to the industry and its organisations. It then focuses on the patient, the development and production of medical devices, and finally, their sale.

The Patient

• Participants are introduced to anatomy and physiology. They then gain insight into how to use and conduct market analyses, enabling them to gain a better understanding of patients’ needs.

Development and Production

• The course provides an overview of EU legislation on medical devices and quality management (ISO 13485), including the rationale behind the extensive documentation and registration requirements. Through practical examples, participants gain insight into the challenges involved in the development of medical devices, including risk management, biosafety, and materials selection.

Various aspects of medical device production will also be addressed, including hygiene requirements for personnel, facilities, and equipment, as well as an introduction to sterilisation processes.

The course also covers how clinical trials are conducted when medical devices are tested on patients. Finally, participants will receive an overview of the rules governing the sale and marketing of medical devices in Denmark, including an introduction to EU public procurement rules and the Danish Sale of Goods and Contracts Act.

Trainers

The training is delivered by a number of industry professionals, each of whom provides insights into their area of expertise.

What previous participants said

Contact

Morten Petersen

Uddannelseskonsulent | Training Consultant

49 18 47 03
mp@medicoindustrien.dk