ISO 14971 Risk Management Software

Challenge

Key Pain Points in ISO 14971 Risk Management

Effective risk management in accordance with ISO 14971 is a key prerequisite for regulatory approval of medical devices in international markets.

Fragmented documentation complicates implementation: The individual steps of risk management are often maintained in separate spreadsheets or documents, using different methods and formats.
Risk management is handled separately and is not integrated with the design control process.
Impact: The relationships between hazard analyses, risk evaluations, risk control measures, and evidence of effectiveness are difficult to trace.
Isolated risk management has little influence on design decisions.
Transparency is lost, the effort required to maintain changes increases, and compliance with ISO 14971 and ISO 13485 can only be demonstrated with significant effort.
Root cause: The lack of a centralized structure and continuous linkage between risk management activities and design controls leads to inconsistencies and increased complexity.
Delayed internal and regulatory approvals: Inconsistent documentation and limited transparency extend review and approval cycles.

Without a structured risk management approach, you risk additional questions from regulatory authorities, delays in internal and regulatory approvals, and — in the worst case — product recalls.

Solution

ISO 14971 Software for Structured Risk Management

At the core of our software are the regulatory-relevant processes of risk assessment, risk control, and overall residual risk evaluation in accordance with ISO 14971 — fully integrated with requirements management as well as design and process FMEA.

Consistent methodologies: Standardized risk management methods and clearly defined rating scales ensure consistent, traceable, and standards-compliant risk evaluations.
Centralized data foundation: All risks, hazards, and control measures are managed in a unified system and kept up to date at all times. Links to design inputs, design outputs, verification, and validation ensure full traceability.
Efficient change management: Updates and additions can be made quickly without creating inconsistent data sets.
Reliable control measure tracking: The implementation and effectiveness of risk control measures are documented centrally and in a traceable, audit-ready manner.
Improved collaboration: Integrating risk management into the design control process increases user acceptance and reduces coordination effort across teams.
Faster regulatory approvals: Consistent structures and standardized outputs simplify reviews and shorten approval cycles.

With our ISO 14971 software, medical device risk management becomes a reliable and integral part of your product development process.

Benefits

Key features at a glance

Standards-Compliant Risk Assessment

Hazards, initiating events, and hazardous situations are systematically identified, potential harms are described, and risks are evaluated in accordance with ISO 14971.

Centralized Control Measures Tracking

Risk control measures are managed centrally, monitored, and documented with evidence of effectiveness.

Connected System

Integration with solutions for design control, technical risk management (FMEA), knowledge management, and lessons learned ensures seamless, end-to-end processes.

Database-Driven Structure

All content is maintained in a structured, centralized database and is accessible at any time.

Graphical and Tabular Outputs

Results are available at the push of a button as risk graphs, hazard list with risk assessment, or overview of risk control measures.

Web-Based Application

Browser-based access enables easy use, high availability, and efficient collaboration across locations and teams.

SCREENS

Projekte klar steuern – Risiken frühzeitig erkennen

Software screen with an overview of measures — Implementation of Risk Control Measures

Software screen with a risk assessment — Risk Assessment and Risk Control

Software screen with a risk acceptance matrix — Risk acceptance matrix

Our Brands

Quality at the highest level

The PeakAvenue platform combines the strengths of leading expert systems from APIS IT, PLATO, iqs Software, Isograph, and OSSENO Software into an integrated solution for end-to-end engineering and quality management.

Our current software solutions will remain available and will be supported in the long term, while future innovations will be incorporated into the PeakAvenue platform—ensuring a secure, step-by-step transition to a modern, networked software world.

PeakAvenue Plattform

Expert solutions united in one eQMS

The central basis for the quality and development of your products: Seamlessly connect tools, data, and processes for maximum transparency and efficiency throughout the entire product lifecycle.

Quality Center

End-to-end QMS software for long-term quality excellence

Achieve measurable, transparent quality improvements: iqs QC covers the complete quality control cycle - from planning and shop-floor inspection to in-depth analysis.

e1ns Engineering

Optimize product development and quality

Secure product quality from the very beginning: With PLATO e1ns, you manage your development process efficiently and reduce risks—web-based, structured, and fully integrated.

IQ Software

Your benchmark for FMEA and Risk Analysis

Achieve top-tier FMEA and risk analysis: APIS IQ-Software enhances your process efficiency and ensures lasting functional safety and quality.

Isograph RAMS

Expert software for RAMS and Fault Tree Analysis

Master complexity in reliability, safety, and availability: Isograph’s advanced tools empower companies to accurately evaluate and optimize complex systems.

reqSuite® rm

Efficient, intelligent requirements management

Streamline your requirements management - simpler, more structured, and more efficient: reqSuite^®rm from OSSENO Software delivers a top-tier solution that is intuitive, powerful, and enhanced with smart assistance.

Manage Medical Device Risk Management with Confidence

Our ISO 14971 software helps you systematically analyze, evaluate, and control risks in product development — significantly accelerating approval processes.

ISO 14971 Risk Management Software for Medical Devices