Risk analysis

In the field of medical devices, the words risk and risk management are used on a daily basis.
The final purpose of any manufacturer to be able to market a DM in the world market is to bring to the market a device that not only improves the patient's life but is also safe i.e., a product that can be used safely, by the patient and the user.
Risk management can be a difficult topic to tackle. Even the most experienced companies sometimes stumble over it.
ISO 14971 is the standard for the application of risk management to medical devices.
The Maytal consultants are able to support the manufacturers of medical devices in all phases of the risk management process, through:
  • Risk management process design service, supporting the company in defining the risk management process and/or in its critical revision
  • Risk management development service, supporting the manufacturer and in particular the R & D area from the early stages of the product design phases, throughout the development process
  • Risk management assessment, aimed at verifying the compliance status of risk management documentation before submission to the Authority (eg FDA) or to the Notified Body for CE marking