Medical Device Safety Audit (BGV A3)

Auditing Medical Devices

Whether it's ECGs, examination tables, patient lifts, or ultrasound equipment, we can determine the condition of your medical technology. Our experts carry out statutory audits for operator and patient safety before initial operation, recurrent, and also following repairs. This means you can identify existing and potential faults in equipment safety, helping to reduce the risk of accidents and burns for personnel and patients alike.

Benefits at a Glance

With TÜV Rheinland as your partner for safety audits of your medical devices, you:

  • Guarantee precise diagnoses for your patients, and functional and qualitative use of your medical devices
  • Fulfill operator responsibilities, get legal peace of mind, and ensure insurance protection in line with statutory accident insurance
  • Establish an intelligent audit deadline management system that reduces audit costs and duration
  • Won’t ever miss another audit deadline
  • Know exactly which repair work has to be carried out
  • Get all the service you need from one source - we can also include further auditing services in your unique safety package, such as MTK and STK metrological and safety monitoring checks
  • Get support from us - a comprehensive and customer-friendly national service provider
  • Save time when it comes to medical technology administration - we can import the audit data into your device management software

Our Range of Services

Our experts will inspect your medical devices on-site, based on generally accepted technological regulations. We carry out:

  • Visual, electrical, and function inspections
  • Labeling of the audited medical device using a unique barcode test plate
  • Final meeting, evaluation, and instructions on any safety faults
  • Audit deadline management
  • Documentation of results, including audit reports and stat sheets
  • Audit data importing, master data reconciliation in device management software

Statutory Basics

  • Medical devices regulations (Medizinproduktegesetz, MPG)
  • Medical device operator regulations (Medizinprodukte-Betreiberverordnung, MPBetriebV)
  • Health and safety requirements (BGV A3, alt: VBG 4)
  • Workplace safety regulations (Betriebssicherheitsverordnung, BetrSichV)
  • DIN EN 62353
  • Federal and regional authority regulations and guidelines for drugs and medical products (BfArM)

Equipment Examples

  • ECG
  • Suction apparatus
  • Examination lamps
  • Ultrasound devices
  • Laboratory equipment
  • Examination beds
  • Hospital and nursing beds
  • Patient lifts
  • Hub-baths
  • X-ray equipment
  • Sight test equipment