Risk Management is the underlying foundation that helps businesses quantify medical device risks that could impact the patient or medical team. It is a critical part of the medical device product development process.
Often seen as one of the more complex aspects of regulatory compliance, risk management covers everything from device classification to post-market analysis. It is the fundamental driver that leads product strategies, organisational structure and activities. Medical device risk management helps to estimate, evaluate, monitor and control threats. Before releasing a medical device safe for human use, it is imperative to conduct a full risk analysis to show that all medical risks have been carefully considered.
At Patient Guard, we are committed to minimising device risk in your medical portfolio. Our team of specialists will help to ensure that your medical devices are safe and effective. We do this by carefully developing medical device risk management strategies that are 100% compliant with international requirements. We assess how likely it is for the benefits of your new device to outweigh the risks. It is crucial to protect the reputation of your business at all times and to anticipate any post-market issues that could arise.
We offer in-depth training to teams on gold-standard application of medical device risk management. This will allow your team the opportunity to carefully assess and reflect on the potential risk of your medical device.
If you are interested in finding out more about how we can support your medical device risk management process, please get in touch with one of our medical device regulatory consultants.