Risk Management: ISO 14971
Risk Management in the Medical Device Sector
In the medical device sector, the terms risk and risk management are part of daily operations.
The ultimate goal for any manufacturer bringing a medical device (MD) to the global market is to deliver a product that not only improves patient outcomes but is also safe for use by both patients and healthcare professionals.
Risk management can be a complex topic, and even highly experienced companies sometimes encounter challenges. ISO 14971 provides the standard for applying risk management to medical devices.
Maytal consultants can support medical device manufacturers through all stages of the risk management process, including:
Risk Management Process Design: Assisting the company in defining or critically reviewing the risk management process from the initial identification of risks to the definition of possible mitigation strategies
Risk Management Development: Supporting the manufacturer, particularly the R&D team, from the early stages of product design through the entire development process
Risk Management Review: Verifying the compliance and completeness of risk management documentation prior to submission to regulatory authorities (e.g., FDA) or Notified Bodies for CE marking
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