Risk Management

Whether you're developing a medical device, industrial machine or consumer product, our structured approach ensures your product meets regulatory expectations and performs safely in the real world.

Risk management is often misunderstood or postponed, but it is crucial to ensure safety, performance and reliability. Common challenges inlude:

• Building a robust and compliant risk management process by selecting the right tools and methods tailored to your product and industry.
• Ensuring smooth certification and market access by aligning your risk management approach with relevant regulatory standards from the start.
• Minimizing costly redesigns by identifying and addressing risks early in the design phase through proactive risk analysis.

We've developed strong expertise in risk management across a wide range of products and sectors, integrating it seamlessly throughout the entire design process. From the earliest design stages, we apply proven methods to identify and assess risks, ensuring that safety, performance and reliability are never compromised.

We identify risks, evaluate them, and implement control and mitigation strategies. Each risk assessment session brings together engineers from various disciplines (mechanical, electrical, software and field application) to ensure all potential risks are covered from every angle.

Our approach is grounded in thorough documentation practices and traceability. Quality and transparancy are mainatined, linking risks to requirements, verification methods and records. We perform design, process and user-related risk assessments tailored to each product.

Beyond product risks, we also manage project-related risks such as timeline, budget and scope.

A key method we rely on is Failure Modes and Effects Analysis (FMEA), a structured technique used to anticipate potential failure modes, evaluate their impact, and define mitigation strategies early in development. For medical devices, we follow ISO 14971, identifying hazardous situations that could lead to patient harm. For machinery, we adopt risk assessment method according EN ISO 12100.

This proactive approach helps us catch issues before they arise and design with confidence.

In the healthcare industry, where patient safety and regulatory compliance are critical, our risk management practices are also backed by our ISO 13485-certified Quality Management System and deep in-house medical expertise.