MDR certification „package“ / Helping you to make your medical devices MDR-compatible

The European Medical Device Regulation (MDR 2017-745) transition period for Class I products ends on 25th May 2021. For manufacturers of medical devices this means: new requirements for technical documentation, market surveillance and risk management.

These requirements also apply to user interfaces. steute Meditec has prepared for this and is able to offer its customers – international manufacturers of devices and equipment from numerous medical disciplines – a documentation package covering the steute components, all ready for inclusion in the overall device documentation.

Our user interfaces come with all the documents necessary to support medical device manufacturers with their MDR certification process – from risk analysis in compliance with ISO 14971 and documentation of software safety in compliance with IEC 62304 (up to Class C), through design FMEA and process FMEA, to traceability of individual interfaces.

With this support, medical device manufacturers need invest considerably less time and effort in testing and documenting and can concentrate on a confident market launch under new MDR conditions.