Calibrating and Verifying Your Medical Equipment
Whether it’s radiation thermometers, blood pressure monitors, or audiometers – are you sure your medical devices perform within the range of acceptable errors in measurement? Our experts can run quality and safety tests on your medical equipment - and document its reliability in the legal record for medical devices. The tested devices are all marked with individual bar codes.
Benefits at a Glance
Let TÜV Rheinland measure the reliability of your medical equipment to:
- Ensure precise diagnostics, technical quality, and the safety of both patients and device operators
- Gain legal security by fulfilling your requirements as an operator of medical devices
- Never miss another inspection
- Save money - because our testing agents are not there to try and sell costly repairs
- Find out exactly what needs repairing - and demand exactly that
- Benefit from our neutrality in testing and from our years of experience
- Get an individual safety package with additional testing services
- Receive one-stop service - because we collaborate with the Bureau of Standards and with testing laboratories accredited by TÜV Rheinland
- Draw on the support of the nation's leading service provider in medical technology
- Save time on your technical paperwork - because we import the test data into your device management software
Our Metrological Testing (MT) Services for Medical Equipment
Our experts run on-site inspections of your equipment. The tests follow standard and manufacturer-specific guidelines. We are responsible for:
- Visual inspection, quality and performance testing, and determining compliance with limits on measurement error.
- Marking tested devices with individual bar codes.
- Final evaluation and discussion, including information on safety-related defects.
- Documenting the results with test reports and statistics.
- Providing advice on liability issues that may arise from various regulations on medical devices.
- Importing test data into device management software - and comparing it to master data.
Legal Standards for Our Services
- Law on medical devices (Medizinproduktegesetz, MPG)
- Regulation on medical device operators (Medizinprodukte-Betreiberverordnung, MPBetreibV)
- MPBetreibV Appendix 2 (in connection with MPBetreibV § 11)
- Guide for metrological testing of medical measurement devices (Leitfaden zu messtechnischen Kontrollen von Medizinprodukten mit Messfunktion, LMKM)
Examples of Devices We Test
- Blood pressure monitors
- Temperature gauges
- Infrared radiation thermometers
- Temperature sensors
- Tone and speech audiometers
- Foot ergometers
- X-ray equipment