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The legal situation for medical devices does not only include requirements for the products. Responsibilities are also regulated for the organization of the manufacturing company. According to the Medical Devices EU Adaptation Act (MPEUAnpG), the medical device consultant is responsible for fulfilling the obligations within the framework of post-market surveillance and for advising/selling the products. These market observation obligations involve, among other things, tracking the use of the products. Damage to patients, users and third parties that has occurred, as well as any deviations from the intended use, must be reported to the safety officer or the responsible person. Even trends or observations on comparable competitor products and alternative methods may have to be fed into your own internal reporting chain. All of this is of course particularly interesting if you only work as a trading company or distributor on the market. In the one-day seminar, the requirements for medical device consultants as well as their tasks and duties are worked through. Practical examples illustrate the topic.
topic overview
- Introduction to the Medical Devices EU Adaptation Act and EU MDR
- Classification of products and the consequences thereof
- Safety requirements by considering the product in a therapeutic environment
- Instructions for use, labeling and risk management
- Medical product consultant: task and communication requirements
- What is reportable?
- reporting deadlines
target group
Managing directors, those responsible for placing the product on the market, safety officers, responsible persons, sales managers, sales employees and medical device consultants.
previous knowledge
Not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
