Safety and reliability as top priority.

In the product development of medical devices are 4 quality management processes in focus:

• Design Control
• Risk management
• Document management

PLATO e1ns offers a solution package that ensures consistency from requirements to risks to verification and validation. Due to the model-based data model of PLATO e1ns, redundant data or time-consuming data maintenance after changes are a thing of the past.

PLATO e1ns with its extensible method kit also offers the possibility to implement further standards (ISO 60601, ISO 62366 etc.).

PLATO XERI™ Document Management guarantees the systematic and standardized control of documents in your organization.

From Requirements Management to the complete integration of Risk Management into the product development - PLATO has the solution for your development process of medical devices.

PLATO Design Control: Keep track on all your requirements - from the first idea to the final product.

PLATO Risk Management 14971: Prove that your medical device offers more benefits than risks.

PLATO Technical Risk Management: Identify complex interactions and avoid expensive product recalls at an early stage in the product development process.

PLATO e1ns provides all these methods and data on one data basis so that redundant data or complex data maintenance are now things of the past. e1ns also offers an expandable method toolbox which can be used to implement further standards (ISO 60601, ISO 62366, ...).