Risk Management for Medical Devices

How do you ensure that risks in your product development are always documented? Do you have a system that enables seamless documentation from the development phase right up to the control plan for production? And is your documentation resource-efficient?

Products for medical use are subject to regulatory requirements. Among others, relevant harmonized standards, such as DIN EN ISO 13485 and DIN EN ISO 14971, need to be considered. The risk-based product development approach and thus the requirement to comply with DIN EN ISO 14971 “Application of risk management to medical devices” are becoming increasingly important as far as the manufacturers of medical products are concerned. With all medical devices, it is essential to compare the benefits of the product with the related risks for the patient, user, third parties and environment.

The key elements of a risk management process include risk analysis, risk assessment and risk governance. Available information on risk identification is methodically evaluated, the resulting risks assessed and any necessary action to reduce risks ascertained.  With the aid of suitable methods for the type of risk involved (technically or user-induced), an analytical risk analysis is performed to systematically identify all risks. Risk assessment is based on the fact that a risk is the probability of damage occurring and the consequences of the resulting damage. If the risk-benefit ratio demands that action be taken (regarding the product concept, design or information), this must be documented in a traceable manner.

Fraunhofer IPA has extensive experience in conducting risk analyses and helps you to:

  • apply risk management to medical devices DIN EN ISO 14971,
  • conduct technical risk analyses (product and process) with the aid of Failure Mode and Effects Analysis (FMEA),
  • assess all risks from the design through to the production process and control plan as well as
  • identify risks, anticipated sequences of events and risk situations.