Post-Market Surveillance in Medical Devices
Post-market surveillance (PMS) is pivotal to ensuring the real-life safety of medical devices in healthcare settings. The Medical Devices Regulation (EU 2017/745 MDR) offers a tangible and legally enforceable definition of what is included, as well as the responsibilities held by manufacturers to ensure its successful implementation.
But how can device manufacturers make PMS an effective and dynamic process, as opposed to yet another regulatory hoop to jump through? By adopting a proactive approach to PMS, incorporating surveillance considerations into the software development lifecycle of the product, manufacturers can avoid the scramble for evidences to submit to Notified Bodies (NBs) defined under MDR and maximise safety when released to market.
In this white paper, discover:
- The PMS requirements defined by the MDR
- How proactive PMS within software design helps avoid difficulties after the product goes to market
- Functionalities which can help devices gather necessary evidence to submit to NBs, from data collection to pre-processing
- IoT and Artificial Intelligence and how they can simplify PMS activities while improving evidence quality