Solution: Reports and incident investigation

Reports and incident investigation for medical devices

Target group

  • Hospitals
  • Rehabilitation centres
  • Nursing homes
  • Medical practices
  • Outpatient clinics
  • Health spas
  • Physical institutes
  • X-ray, MR, CT institutes
  • etc.

Legal & normative bases

Medical Devices Act, MPG

Procedure of the service

  • Secure the medical device with all accessories. Disposable items that have been used must also be kept.

  • Report the incident to the Austrian Federal Office for Safety in Health Care (BASG).

  • We will be happy to provide you with a quotation for the services you require. After your order confirmation, a test technician will contact you to arrange an individual appointment.

  • The further procedure will be discussed individually. In most cases, the device and all its accessories are taken to our test laboratory for further testing.

  • Interviews about the incident are also being held with all affected persons.

  • On the basis of the above mentioned content, you will receive an expert opinion and all examined material back from us.

In which region do you need this solution?

  • All regions

Medizintechnik / Krankenhaustechnik - TÜV AUSTRIA Group

+43 5 0454 6501

Send email

Deutschstraße 10 1230 Wien Österreich

TÜV AUSTRIA SERVICES GMBH

Region: Österreich

+43 5 0454 0

Send email

Deutschstraße 10 1230 Wien Österreich

Reports and incident investigation
for medical devices

The risk of incidents or close calls in connection with medical
devices or technical equipment (medical products, electrical
systems etc.) must be minimized in principal.

Should something nevertheless happen, the cause of the
incident must be thoroughly investigated. TÜV AUSTRIA
experts will help you determine the cause(s) of an incident
or close call and generate the corresponding report.

Your advantages

  • Benefit from our decades of experience in the field of medical technology, the high level of expertise of our staff and our collaboration on norms and standards.
  • We have access to experts from other specialist departments as well an independent pool of experts for complex investigations and problem solving.
  • Our test reports and expert opinions are recognized internationally and in court as an accredited body and create legal certainty for you.
  • We are objective, have no close or dependent relationship with industry, trade or authorities and are not bound by instructions in our assessment.

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