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.
Close the gap between standards compliance and technical risk analysis
PLATO e1ns masters complexity
Consistency of risk requirements for review and risk control
No document dependencies, changes immediately available
Create acceptance in your development team
PLATO e1ns guarantees compliance with standards
PLATO e1ns ensures transparency
Since the correct application of ISO 14971 is a prerequisite for other standards such as IEC 62304, IEC 62366 and IEC 60601-1, the importance of ISO 14971 and therefore of risk management activities is paramount. PLATO e1ns provides risk management data at the push of a button, which is attached directly to the approval file of the medical devices.
Documentation plays an important role in the GxP-regulated areas. Creating, releasing, providing and searching all kinds of organizational documents - all this is very easy with PLATO XERI™. Live search, tagging, storable search filters make it easier for your employees to get the right document. Companies can customize the document management software XERI™ by creating graphical entry pages.
Your advantages at a glance
To this day, medical technology is, besides the automotive industry, the industry with the strongest awareness of FMEA and risk management and causes that companies, from small and medium-sized businesses to corporations, look to the experiences there in many areas.