It is a big undertaking to publish manuals online. The EU-MDR requires this in 23.1 GSPRs, and every manufacturer with a website must make this information available online. What sounds simple at first glance has a few pitfalls.
- The publication must be in line with the own technical documentation and must be kept up to date.
- Release processes are necessary, which means more work
- Document redundancies are created
- A clear version control must be given
- Access to older versions of the instructions for use must be possible if different versions of a medical device are on the market
Our developers have therefore come up with something special. The digital technical documentation is already managing the IFU. Therefore, we are now expanding our meddevo cloud with a new module: meddevo eIFU. A synchronized publication of user manuals under your domain.
In 2020 meddevo cloud customers will receive the eIFU module free of charge.