Risk Assessment – ISO 14971

Risk Assessment - ISO 14971

Risk assessment is a key component of Technical Documentation for medical devices. The risk assessment process ensures that medical device manufacturers suitably consider and mitigate the potential risks associated with the use of their device as part of the product development and eventual certification process.

KD&A recommend that the internationally recognised standard ISO 14971 be used to assist manufacturers in the process risk assessment and mitigation.

Risk mitigation can come in many forms – however there is a general hierarchy of mitigation activities:


  • Design

Device design should consider the intended purpose and user of the device. Risks associated with material biocompatibility, degradation, structure, sterilisation, etc should be considered when finalising a device design.


  • Product Verification/Assessment

The design should be verified and assessed to ensure the device performs as intended and is safe. These activities can include design verification, clinical evaluation, bench testing such as biocompatibility, electrical safety and EMC, etc. 


  • Information provided to the user regarding remaining risks

It is not always possible to fully mitigate risks associated with a medical device. In this scenario, device manufacturers must provide sufficient warning and guidance to users and others who may come into contact with the device. This information is generally provided in the form of instructions for use and labelling.


Risk assessment is best carried out in a group environment – factoring in those who may use or come into contact with the device. There a large number of risk assessment techniques which can be used dependant on product type, the most popular being FMEA (Failure Mode and Effects Analysis).

KD&A can assist your organisation to complete and document risk assessment according to ISO 14971. Contact us for a personalised quotation.