Risk analysis is an essential component of your quality management system. A mandatory task for every new medical device about to hit the market, risk analysis is universally recognised as part of the ISO 14971 standard of practice. Experienced medtech quality consultant, Christine Stemmer, walks us through the process.
Risk analysis is your first step towards regulatory compliance, as you set out to identify, assess and mitigate every potential hazard your device can bring to your stakeholders. It is usually a product of collaboration between your regulatory, clinical, manufacturing and design teams to propose a safe and effective new product on the market.
Founder of Strasbourg-based medtech consultancy firm Horizons Qualité, Christine Stemmer has been helping French startups obtain quality certification and develop organisational processes for over ten years. She believes that a risk analysis performed early on in the design stage can reduce disruption, cut down on service and support costs, lower the likelihood of customer complaints, and promote innovation.
‘Although implemented early, risk analysis and management will be relevant throughout the lifecycle of your product,’ she explains.
‘For each external factor of your device – from design and shape to biocompatibility – you have to identify the potential danger, its cause and consequences, then decide how you will manage it.’
While it’s during the design stage that you start thinking about your most common risks, it’s during the clinical trial phase that you encounter any unpredictable risks and test out how to overcome them. With every new adverse event, you have to review your risk analysis to see what you missed, and if you had the right action plan. Restarting your risk analysis can be done as often as it’s necessary.
Even after commercialisation, patient or user dissatisfaction may arise so your post-market surveillance will focus largely on preventing new risks, according to Stemmer.
Because your risk management plan will be reviewed by Notified Bodies as part of the standard regulatory compliance procedure, you should be prepared to show a record of your identified risks: a technical file detailing the characteristics of each risk, their causes, consequences, likelihood of occurrence, severity, and proposed actions to mitigate.
For maximum efficiency, all your risk management practices must be data driven, with logical, consistent risk characterisation that is well communicated across the organisation.
In the event of a patient incident, the authorities will look over this technical file again to file to establish whether the hazard may have been foreseen with a rigorous and objective risk management effort. If signs of neglect are discovered, your device could be recalled.
‘I cannot overstate how important it is to have the right team to identify your device’s potential risks. From your KOLs and early adopters to your design and manufacturing experts, seek a variety of input and engage with it throughout the product lifecycle,’ Stemmer says. A robust risk analysis will streamline the regulatory process that will enable your entry into your target markets.
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