Archiv - Medical Device Consultant: Definition and Tasks
Über den Vortrag
Der Vortrag „Archiv - Medical Device Consultant: Definition and Tasks“ von Prof. Dr. Christian Johner ist Bestandteil des Kurses „Archiv - Medical Devices Act“. Der Vortrag ist dabei in folgende Kapitel unterteilt:
- Definition Medical Device Consultant
- Activities: Legal Requirements
- Types of Problems
- Expertise
- Summary: Medical Device Consultant
Quiz zum Vortrag
Who typically is a medical device consultant?
- Operation consultant.
- Member of the field staff.
- Risk manager.
- The management.
Who are typically considered expert groups?
- Doctors.
- Medical technical assistants.
- Caregivers (also in surgery).
- Informed patients.
- Reviewers specialized in medical technology.
Which activities does the medical device consultant have to perform in order to meet legal requirements?
- Report medical device risks to the manufacturer or its safety officer.
- Record in writing notifications from expert groups about malfunctions.
- Report medical device risks to the corresponding public authority.
- Instruct the expert groups, for example, through training.
The endoscope breaks when being introduced into the patient’s body. The patient is not injured. Does the medical device consultant have to report this?
- Yes, because there was technical defect.
- No, because the surgeon probably just applied too much force.
- Yes, because this is a so-called “mutual influence” between the endoscope and the patient’s body.
- No, because nothing really happened.
When and how do medical device consultants need to report?
- Immediately and in writing.
- Without further delay (typically on the same day) to the safety officer or the manufacturer.
- Depending on the level of urgency, either by telephone or by email or mail.
- On the next QA meeting at the latest and in writing.
What does a report from the medical device consultant have to include?
- Information in order to identify the device.
- The person who is reporting (meaning information about the medical device consultant).
- If possible, details to reproduce the problem.
- Reference to the (probable) culprit.
What is the minimum level of expertise that a medical device consultant is required to have?
- A professional qualification in natural sciences, medicine or for a technical occupation, and proven training in the use of the respective medical device.
- A professional qualification in natural sciences, medicine or for a technical occupation, or proven training in the use of the respective medical device instead.
- A university degree in natural sciences, medicine or for a technical occupation, and proven training in the use of the respective medical device.
- A university degree in natural sciences, medicine or for a technical occupation, or proven training in the use of the respective medical device instead.
Dozent des Vortrages Archiv - Medical Device Consultant: Definition and Tasks
Prof. Dr. Christian Johner
Christian Johner ist Professor für Software-Architektur und Software-Engineering an der Hochschule Konstanz. Er ist (Co-)Autor der Bücher „Basiswissen medizinische Software“ und "Usability Engineering — Effizient IEC 62366- und FDA-konform dokumentieren“ sowie eine der treibenden Kräfte des Zertifizierungsprogramms „Certified Professional for Medical Software“. Als Inhaber der Johner Institut GmbH berät er gemeinsam mit seinem Team zahlreiche Medizintechnikhersteller in Europa und den USA bei der Entwicklung und Zulassung medizinischer Software, speziell dem Erstellen der „technischen Dokumentation“ und dem Aufbau von QM-Systemen. Er unterstützt und schult auch benannte Stellen, für die er einen Auditleitfaden entwickelt hat.Dr. Johner hat mit dem Auditgarant eine Plattform mit Videotrainings und Templates geschaffen, mit dem Medizinproduktehersteller in die Lage versetzt werden, eine gesetzeskonforme Produktakte zu erstellen und Audits sicher zu bestehen.
Kundenrezensionen
5,0 von 5 Sternen
| 5 Sterne |
|
5 |
| 4 Sterne |
|
0 |
| 3 Sterne |
|
0 |
| 2 Sterne |
|
0 |
| 1 Stern |
|
0 |
