Risk Management
Our approach is methodical and grounded in thorough analysis, ensuring that we identify and mitigate potential risks effectively.
What Risk Management involves
Project level risk management
We address project-level risks encompassing business, project, and product aspects. This includes assessing success probability, ROI, market readiness, feasibility, scope clarities, and challenges regarding the production environment. Our goal is to identify potential hurdles at an early stage and manage them effectively.
Risk Management for non-medical devices
For non-medical hardware projects, we adhere to recognized risk management standards such as IEC60812, ensuring that your products meet the highest levels of safety and reliability.
Risk Management for medical devices
In medical hardware projects, we focus on user-related risks, particularly where patient harm and critical factors are concerned. We rigorously follow ISO14971 for medical devices, conducting comprehensive risk assessments and mitigations to ensure user and patient safety, as well as reliable device functionality.
How we execute Risk Management
Utilization of Failure Mode Effects Analysis (FMEA)
We employ FMEA to assess both user-related and production-related risks, analyzing potential failure modes and their impacts. This thorough evaluation is a cornerstone of our risk management process. Risk management processes are integrated into our quality plans, ensuring that risk mitigation is a fundamental aspect of our quality assurance procedures.
Cross-functional collaboration for comprehensive Risk Management
Our approach to risk management involves cross-functional collaboration, combining expertise from engineering, quality assurance, production, and other relevant departments for a holistic approach.
Ensuring quality
Compliance with IEC60812 for non-medical norms
On non-medical projects, our compliance with IEC60812 reflects our commitment to applying recognized standards for risk management. We continuously monitor and update our risk management strategies to reflect changes in project scope, industry standards, and emerging risks, ensuring they remain effective and relevant.
Documentation and traceability of all Risk Management activities
Meticulous documentation and traceability are maintained for all risk management activities, from risk identification to mitigation strategies. This ensures accountability and enables continuous improvement in our processes.