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 following repairs, with the advantage of being able to detect existing and potential faults in equipment safety, helping to reduce the risk of accidents for personnel and patients alike.

Benefits at a Glance

With TÜV Rheinland, organization recognized internationally for its expertise in the medical devices, you:

  • Guarantee precise technical diagnoses on the products subject to verification and control
  • Fulfill operator responsibilities, get legal peace of mind, and ensure protection in line with statutory accident insurance
  • Know exactly which repair work has to be carried out in the face of technical negative checks

Our Range of Services for control checks on medical devices

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

Legal and regulatory

  • Medical devices regulations
  • Medical device operator regulations
  • Workplace safety regulations
  • EN 62353

Equipment Examples

  • ECG
  • Suction apparatus
  • Examination lamps
  • Ultrasound devices
  • Laboratory equipment
  • Examination beds
  • Hospital and nursing beds
  • Patient lifts