Technical Safety Controls for Medical Technology

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.

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 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

• 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

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