Anyone operating medical devices bears responsibility for their safety – towards patients, staff and authorities. Three reference points shape day-to-day work in Switzerland and Europe.
The most common weaknesses are not a lack of knowledge but incomplete documentation, scattered test records and unclear responsibilities. That is exactly what stands out in an audit – and creates liability risks.
Three levers reduce the risk significantly: a complete device inventory, a clear maintenance and inspection plan, and central documentation available at any time. Proactive maintenance additionally increases device availability and thus patient safety.
Important: compliance is not an end in itself. Cleanly documented processes save time in audits, reduce costs and build trust – internally and externally.
FAQ
Swiss institutions follow the Medical Devices Ordinance (MedDO); the MDR additionally shapes products and supply chains. Clean documentation largely covers the requirements of both at once.
This depends on the device type and manufacturer specifications. An inspection plan based on IEC 62353 defines the intervals in a traceable way.
We align maintenance and documentation with MDR, MedDO and IEC 62353 – fully traceable documentation, ready for your next audit.