The efficient route to technical documentation
The regulatory requirements on the development and distribution of medical devices have increased continuously over recent years. The EU Medical Devices Ordinance has been the subject of intense discussion. For the manufacturers of medical devices, this means more and more documentation work. After all, in case of doubt, unless it is documented, it probably wasn’t done. Manufacturers of medical products, in-vitro diagnostics or active, implantable medical devices therefore currently produce mountains of paperwork. And this trend is only increasing.
To break free from this tangle of red tape, the aim should be to break down monolithic documents into fine-grained data and have as many work steps as possible handled by specialized software solutions.
As the globally leading software solution, BAYOOSOFT Risk Manager supports you in preparing technical documentation for medical devices and in-vitro diagnostics. All relevant information is recorded in a clearly structured environment, stored in a central, audit-proof manner and dynamically connected with each other at a fine-grained level. This means you automatically avoid redundant data keeping. Reports are generated with the most up-to-date data at the press of a button.
BAYOOSOFT Risk Manager includes a dedicated administration area. Here you can import or create backups, define templates for risk graphs or FMEA catalogs as well as create or change descriptions of test procedures. There are many ways to add and maintain existing knowledge in the knowledge database, as well as manage master data and standard templates. Since every company has its own quality management handbook, type tests can be adjusted based on, for example, how a project, version, hazard or measure number is structured and the degrees of freedom with which users can act.