In case you missed it … a chance to watch PS Partnerships’ Suzanne Johnston and her presentation ‘Top tips for getting started with ISO 14971:2019’.
Pretty much every day we do something that involves risk … whether that’s driving to work or shops, going out on a bike 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’s a systematic process centred around product hazards when using the medical device … from concept and design through to decommissioning and disposal.
ISO 14971:2019 – Application of risk management to medical devices is a global risk management standard that has been updated to keep up with regulatory and technological changes in the medtech industry.
ISO 14971:2019 provides internationally recognised methods to support you in bringing a compliant product to market. This presentation, given at the PS Partnerships & Consultancy webinar ‘Brexit, EU MDR and Medical Device Risk Management’ runs through some great pointers on how to get started and understand more about this important standard.