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Tips to get started with ISO 14971:2019

Tips to get started with ISO 14971:2019


Pretty much every day we do something that involves risk … whether that’s driving to work or the shops, going out on a bike ride or even the habits we have.

But most of the time we don’t really think about the risk, we take it for granted and decide that the benefit of the action justifies its cost.  Like getting on a plane to a far off destination for some summer sun.

For medical device manufacturers, risk management is a vital aspect of the lifecycle of your product. It goes beyond product development and manufacturing.  It is a systematic process centred around product hazards when using the medical device … from concept and design through to decommissioning and disposal.

ISO 14971:2019 provides internationally recognised methods to support you in bringing a compliant product to market.  It is should be used as a framework ‘within which experience, insight and judgement are applied systematically to manage the risks associated with the use of medical devices‘.

ISO 14971:2019 requires manufacturers of medical devices to carry out risk analysis of their device.  There are plenty of tools to help with this process; FMEA, Preliminary Hazard Analysis (PHA) Event Tree Analysis, HAZOP … and all have their own advantages and disadvantages.

ISO/TR 24971:2020 has lots of guidance on risk analysis techniques that can help – and so do PS Partnerships!  PS Partnerships & Consultancy Ltd have put together a few quick tips to help you understand a bit more about this important standard. Or register for our webinar to find out more.

We have also developed training and support for businesses wanting to implement or improve their medical device risk management processes.  Get in touch at if you need guidance on using ISO 14971:2019 for risk management.

Get a copy of the standard graphic Don't forget ISO/TR 24971 graphic Everything starts with a plan graphic Document intended use graphic Reasonably forseeable misuse graphic Hazards, hazardous situations & harm graphic Designed without ISO 14971 graphic