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Risk Management

In our Design Control team, risk management is considered a core capability, and we are experienced in analyzing potential risks related to the product in cooperation with different stakeholders. Our specialists work according to ISO 14971 and MDR requirements for risk management procedures.

Initiating risk management activities in a timely manner is an important part of the development of a medical device. It facilitates support and input to concept development and ensures establishment of Risk Assessment and Requirements Specification that are consistent with the development process. This ultimately leads to optimization of project costs.

One of the main objectives of our risk management efforts is to facilitate coordination between the stakeholders behind the intended purpose, e.g. RA, QA, CLI and R&D. This helps ensure that risks associated with the use of the device, the user group and the surrounding environment are identified and addressed in the device design and labeling. Our specialists are experienced working in close collaboration with the design team and clinical experts to ensure accuracy in risk assessment. With a deep technical understanding of the medical device, our team can help identify and document possible risks and solutions.

Our Risk Management deliverables include: