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. 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 Federal and regional authority regulations and guidelines for drugs and medical products BfArM Equipment Examples.
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VBG 4 / BGV A2 / BGV A3 / TRBS 1201
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