Risk analysis

A risk analysis not only serves to ensure the safety of the patient, but also to protect the manufacturer of a medical device if you are held liable for your product.

For risk management and risk analysis, there is DIN EN ISO 14971, which is currently available in the July 2020 version.

Possible methods are

• Hazard Analysis (HA)
• Fault Tree Analysis (FTA)
• Failure mode and effects analysis (FMEA)

My offer

• Carrying out the hazard analysis (HA) in collaboration with your specialists
• Carrying out the FMEA in collaboration with your specialists
• Documentation of the results