Medical Product Consultant: Defintion of Important Terms
Über den Vortrag
Der Vortrag „Medical Product Consultant: Defintion of Important Terms“ von Hans-Jörg Gröber ist Bestandteil des Kurses „Instruction for Medical Product Consultants (EN)“.
Quiz zum Vortrag
Can software be a medical product?
- If the software is used for medical purposes, it is automatically classified as a medical product. It is classified according to the use and risk, and subsequently evaluated.
- No, software is only an accessory, and thus not a medical product.
- No, only physical products can be considered medical products.
- Only if it serves towards making diagnoses and treating diseases or injuries, but not if it is merely an operating system.
Are accessories also fully assessed and certified in accordance with MDR and MPDG?
- Possible accessories are listed within the framework of the CE conformity assessment; however, they are not an independent medical product in the sense of the MDR/MPDG.
- Yes, they must be fully assessed and approved individually.
- It depends on how the user uses the accessories.
- Users are completely free when it comes to the choice of accessories, but they may only use CE-approved equipment.
Are there any medical products that do not bear a CE Mark?
- Yes, for example, custom-made devices.
- Medical products must always bear a CE mark, which is followed by a 4-digit number.
- Medical products generally do not bear a CE mark, but rather an MDR identification number.
At the medical facility of a client, you discover an energy-transmitting, active therapy device that only has a CE mark, a country of origin, and a serial number on the nameplate. How should you react?
- You must draw the client’'s attention to the fact that they have a problem regarding liability law in the event of damages, since they are operating a medical product that has not been approved, and is thus personally responsible for any and all damages that might occur.
- You prohibit the client from operating the device that has not been approved.
- You check the safety aspects of the device and clarify whether it can be certified as safe for use.
- You report the matter to the supervisory authority.
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Dozent des Vortrages Medical Product Consultant: Defintion of Important Terms
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.
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