Medical Product Consultant: Definition, Requirements, and Tasks
Über den Vortrag
Der Vortrag „Medical Product Consultant: Definition, Requirements, and Tasks“ von Hans-Jörg Gröber ist Bestandteil des Kurses „Instruction for Medical Product Consultants (EN)“.
Quiz zum Vortrag
To whom must the Medical Product Consultant report and how?
- You must inform the authorised representative/designated person responsible at the principal's facility in writing or electronically, without delay (within 24 hours).
- You must inform the authorised representative/designated person responsible at the principal’'s facility immediately, by telephone (or SMS/ messenger).
- You must inform the competent authority immediately.
- You must compile a report/log and hand it to/discuss it with the client at the earliest opportunity (e.g., QA meeting).
- You must send an email to the management at the principal's facility.
What is the minimum level of expertise and knowledge that a Medical Product Consultant must have? (Multiple answers are correct)
- Successfully completed education in a scientific, technical, or medical field and training on the medical products in question.
- At least one year's experience during which the person in question gained proven experience in handling the product and briefing others in the use thereof.
- Successfully completed training in a scientific, technical, or medical field, or alternatively, training on the medical products in question.
- Successfully completed degree course and training in a scientific, technical, or medical field and training on the medical products in question.
- Successfully completed degree course in a scientific, technical, or medical field, or alternatively, training on the medical products in question.
A Back Office Medical Product Consultant (Call Centre) receives a call from a patient asking for information about the use of a medical product for the medical condition he suffers from. Are you permitted to help him in this respect? (Multiple answers are correct)
- No, the consultant may only provide basic technical data. Generally, queries from patients must be forwarded to persons/institutions who are authorised to provide medical treatment.
- You refer the patient to his medical practitioner and offer to inform the practitioner about the medical product and the use/benefits thereof.
- Based on your experience with the medical product in question, you may advise the patient whether or not the product could help him.
- You send the patient information materials and therapy instructions.
You become aware of the misleading wording in the instructions for use of a medical product that you have received instruction on, which led to a potentially dangerous operating error. How do you react?
- You report the matter to the responsible person at the manufacturer's facility immediately, and they determine the appropriate corrective measures (recall, rectification, etc.), which must then be implemented. If there is imminent danger, you suspend the use of the device.
- You explain the correct procedure to the user/operator again, with a written note if necessary, and ask him/her to follow your instructions precisely.
- You change the instructions for use on your own initiative, or explain the misleading wording with a note inserted in the instructions for use.
- You make a note of the issue and discuss it with the manufacturer of the medical product at the next opportunity (e.g., QA meeting).
For which products are you a qualified Medical Product Consultant?
- Only products for which you have received training, and for which you keep your knowledge up to date.
- Generally, for any medical products.
- For all products that are comparable to the medical product for which you received training.
- You qualify for one or more risk classifications (I, IIa, IIb, III) and give advice within the context of the risk classes you have been approved for.
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Dozent des Vortrages Medical Product Consultant: Definition, Requirements, and Tasks
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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