Risk Analysis

Risk Analysis

• Evaluate usability along with risk analysis, an integral part of risk management, in order to estimate and evaluate the risks associated with the use, errors of use and ergonomic characteristics of the device with the aim of reducing them as much as possible.
• Our Human Factors Engineering team guides Formative & Summative testing – supporting usability in early and advanced stage development.
• For risk management of your product, an accurate plan and report is provided to evaluate the overall risk.

Risk Analysis - ISO 14971

Effective risk management is essential for compliance with ISO 14971 and global regulatory requirements. It ensures that risks associated with your medical device are identified, evaluated, and controlled throughout the product lifecycle.

Our Services

• Comprehensive Risk Analysis - We evaluate risks related to design, manufacturing, and use of your device including potential hazards, misuse scenarios, and ergonomic considerations with the goal of reducing them to acceptable levels.
• Integrated Risk Management - Our team develops accurate risk management procedures, plans and reports, ensuring traceability and compliance with ISO 14971. We support risk estimation, evaluation, and implementation of risk control measures.
• Lifecycle Approach - Risk management is not a one-time activity. We help you maintain and update your risk files through design changes, verification & validation, and post-market surveillance.