Medical technology companies face the challenge of meeting planned costs and time-to-market as well as integrating regulatory activities into the development process. Keeping an eye on patient safety is a top priority. In order to manufacture medical devices of consistently high quality, the documentation must be comprehensible and complete, the manufacturing processes reproducible, traceable and process-reliable, and the quality of the materials used must be consistent.
Medical devices are becoming more and more complex and the recall campaigns of recent years show that the "technical risk" factor is gaining considerably in importance. For this reason, we are integrating technical risk management into PLATO e1ns, which has been adapted for the medical device industry, in addition to compliance with standards. "PLATO e1ns - Risk Management DIN EN ISO 14971" provides the development accompanying methods for risk management in a common data concept (database). All project participants can access and edit the current data at any time. e1ns links the methods and data in such a way that redundant data and time-consuming data maintenance are a matter of the past.