How to effectively apply risk management throughout the complete life cycle of medical devices

19 February, 2019

When it comes to develop safe medical devices applying risk management is a central part of all design activities. A risk-based approach is often chosen not only during development but also along the product life cycle to come to reasonable design decisions. Therefore, it is no surprise that risk management plays an important role in the new MDR 2017/745: “Risk” is mentioned more than 240 times whereas quality only gives 135 hits. Highly professional risk management not only safes time and money but is the key for safe medical device products. Do it right from the beginning.

The requirement to perform risk management according to ISO 14971 is not new for medical device manufacturers. However, really understanding risk management renders it a powerful tool beyond filling in endless excel spread sheets.

Risk management supports:

  • making smart design decisions at an early concept phase
  • defining product requirements to ensure inherent safety by design
  • finding appropriate design solutions with no safety deficiencies
  • prioritization verification and validation activities
  • reducing re-engineering and change efforts
  • setting the right focus when dealing with customer complaints after launch

Although it may be required to apply various risk management techniques, from FMEA to Fault-tree analysis, to meet the different objectives, the basic principles remain the same. Implementing a versatile yet streamlined risk management can really make a difference not only in quality but also in efficiency.

When you are ready to bring your risk management to a new efficiency level, knoell Germany GmbH can support you by providing skilled expertise specialized in medical device related risk management. We not only know the regulations, but also have profound experience in the practical implementation.

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