Sometimes though, despite your best intentions, situations do happen where a medical device you created is involved in a significant adverse event. In those cases, our job is to look at what happened and try to learn something from it so you can avoid repeating the same mistakes.
To achieve this, you need a system of reporting so that you can generate feedback on your medical devices, including reports of adverse events that involve them – you need post-market surveillance (PMS). We offer you the solution.
You also need to be reporting these events to the relevant regulatory bodies – they want to know that you’re taking the requisite steps to continuously improve your business and manufacturing practices to avoid recurrent problems with our devices. This is mandatory, we help you to achieve this.
Post-market surveillance is now a heavily emphasized requirement in European medical device markets, especially following the release of the European MDR requirements.