Medical Product Consultant: Introduction and Fundamentals
Über den Vortrag
Der Vortrag „Medical Product Consultant: Introduction and Fundamentals“ von Hans-Jörg Gröber ist Bestandteil des Kurses „Instruction for Medical Product Consultants (EN)“.
Quiz zum Vortrag
Is the Medical Products Act, in the current version, purely a national/German regulation? (Multiple answers are correct)
- No, it applies equally throughout the entire EU; only regulations for implementation may be issued at a national level.
- The current Medical Products Act (MDR2017/745) is an EU law; therefore, it is applicable throughout the entire EU.
- Yes, the law only applies to German manufacturers and distributors.
- Yes, the law applies exclusively to the German medical products market.
- The sole purpose of the law is to regulate the market, in order to protect European manufacturers from non-EU imports.
To whom does the European Medical Products Act (MDR), which has been fully applicable since 26/05/2021, apply?
- Basically, it applies to every participant in the European market.
- Only exclusive manufacturers of medical products are subject to this regulation.
- The MDR only applies to new medical products that were introduced to the market after 25/05/2021.
- Only users/operators of medical products must comply with this regulation.
- The regulation applies to all manufacturers and distributors of medical products that originate outside the borders of the EU.
In the sense of the MDR, what constitutes a medical product? (Multiple answers are correct)
- On the basis of the intended purpose, the manufacturer determines whether the product is to be used for medical purposes or is intended for medical use.
- Every product that is used for medical purposes is automatically classified as a medical product, and it must comply with the regulations of the MDR.
- The user/operator determines whether the product must be approved as a medical product.
- The regulatory authority determines whether a product must be listed as a medical product.
- This is determined by the Ministry of Health.
What are the basic tasks of a Medical Product Consultant? (Multiple answers are correct)
- Advise professionals, brief users/operators on the use of medical products and supervise them throughout the use thereof, report incidents/events to the manufacturer or their authorised representative/the responsible person.
- Monitor the market and report any developments or other information relevant to the medical product.
- Record and immediately report (in writing) any notifications of malfunctions or decreasing efficiency received from professionals.
- Report incidents/events with risk potential to the relevant authorities.
- Give lectures and training sessions for those concerned, at medical facilities, about the possibilities offered by the medical product.
Diese Kurse könnten Sie interessieren
Dozent des Vortrages Medical Product Consultant: Introduction and Fundamentals
Hans-Jörg Gröber
Hans-Joerg Groeber, Sportlehrer und Physiotherapeut (1988), Fachlehrer Physiotherapie für physikalische Therapie, Biomechanik, Trainingslehre (seit 1996), eigenes Medizintechnik-Unternehmen mit Muskelstimulation bei Querschnittlähmung und neurologischen Indikationen, seit 1990 medizinischer Fachberater national/international für Medizintechnik-Unternehmen mit den Aufgabenbereichen Produktentwicklung, Anwendungsberatung, Fachvorträge, Marketing und Präsentation.Hans-Joerg Groeber (*1961), Sports Instructor & Physiotherapist (1988), Specialist Lecturer in Physiotherapy for Physical Therapy, Biomechanics, Training Theory (since 1996). He has his own medical technology company, where he offers muscle stimulation for paraplegia and neurological indications, and since 1990, he has been a specialist medical consultant both nationally/internationally for medical technology companies, in the areas of product development, advice on applications, specialist lectures, marketing, and presentation.
Kundenrezensionen
5,0 von 5 Sternen
| 5 Sterne |
|
5 |
| 4 Sterne |
|
0 |
| 3 Sterne |
|
0 |
| 2 Sterne |
|
0 |
| 1 Stern |
|
0 |
