Risk Analysis and Risk Management with meddevo

Risk Analysis: Out of Scope of meddevo

meddevo does not provide functionality for the execution, tracking, or evaluation of individual risks. Specifically, risks cannot be created, tracked, assessed, aggregated, or visualized in matrices within meddevo. Systematic risk analysis as defined in ISO 14971—including risk registers, risk assessment, or follow-up—is not possible within meddevo.

Support for Risk Management Documentation

For technical documentation purposes, meddevo collects a range of information that is also relevant for risk management. The platform can therefore automatically generate framework documents (Risk Management Plan and Risk Management Report) and populate them with existing data from the technical documentation.

Typically, the following data is used to generate these documents:

• Product and system descriptions
• Intended purpose/intended use
• Applicable standards and regulatory requirements
• Listings of components, accessories, and product variants

The Risk Plan and Risk Report generated by meddevo serve as a structured basis for actual risk analysis, which must be performed and maintained outside meddevo—for example, using Excel or dedicated risk management software.

Limitations

Further risk-relevant documents as well as procedures (such as FMEAs, risk matrices, or specific risk listings) cannot be managed, evaluated, or versioned in meddevo. The management of risk control measures and periodic reviews of individual risks must take place in an external system.e your content here.