Technical Safety Controls for Medical Technology

Detect Device Malfunctions on Time

Whether it’s a defibrillator, infusion pump, or electrical stimulation device – people’s lives often depend on the functionality and security of your medical equipment. We can support you with safety checks – normally on an a yearly basis – in compliance with regulations for medical device operators (§ 6 of Medizinprodukte-Betreiberverordnung, or MPBetreibV). So you can spot device malfunctions and dangers before they can affect the health of patients, users, and third parties.

Benefits at a Glance

With TÜV Rheinland as your partners for technical safety checks, you:

  • Fulfill your obligations as an operator and gain legal peace of mind in accordance with medical devices and medical device operator regulations
  • Ensure precise diagnostics, technical quality, and proper use of your equipment for patients and users
  • Benefit from our years of experience and authority in determining results
  • Need never again miss a test date
  • Can save time in administration of medical technology, as we import test data into your device management software
  • Get one-stop shop service from a single source. We can put together an individual security package for you, together with other testingservices
  • Can selectively order repair services
  • Receive nationwide support coverage and customer service

Our Range of Services for Technical Safety Inspections of Medical Equipment

Our experts can check your equipment on-site – in compliance with manufacturer's instructions and generally accepted rules of technology. We can perform:

  • Visual inspections, electrical testing, testing of display / alarm devices, output parameters testing, functional tests
  • Labeling of the audited medical device with an individual bar code inspection sticker
  • Final check, evaluation, indication of safety-related defects
  • Documentation of results with test reports, statistics sheets
  • Test data imports, master data in the device management software
  • Advice on liability issues arising from the medical device regulations or other regulations on medical devices
  • Test deadline management

Legal Standards

  • Medical device regulations (Medizinproduktegesetz, or MPG)
  • Medical device operator regulations (Medizinprodukte-Betreiberverordnung, or MPBetreibV)
  • Appendix 1 MPBetreibV in connection with § 6 MPBetreibV
  • Industrial safety regulations (Betriebssicherheitsverordnung, or BetrSichV)
  • Safety control guidelines with standards such as DIN EN 62353, in-service inspection and testing after repairs of medical electrical equipment

Product Samples

  • Infusion technology
  • Electrical stimulation technology
  • High-frequency surgical equipment
  • Pacemaker technology
  • Defibrillators
  • Patient monitoring
  • Emergency resuscitation
  • Heating appliances
  • Heart catheter technology