All companies that use portable electrical equipment are subject to the testing obligation and regulations of DIN VDE These regulations are the basis for the repeat tests which the legislator is obliged to carry out. This includes an authorised test for all electrical systems and equipment in your company. Our technicians check whether your devices and systems are working correctly; i. The inspection periods specified in Section 5 of BGV A3 vary depending on the use and the potential risks of the equipment being inspected.
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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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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. Our experts will inspect your medical devices on-site, based on generally accepted technological regulations. We carry out:.
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