Post-market clinical follow-up and registries for device manufacturers
Wearable and connected-device data and patient-reported outcomes are brought into one traceable dataset that sits alongside the sponsor's existing EDC, designed to ALCOA++ data-integrity principles and GDPR requirements.
EU MDR post-market clinical follow-up obligations require continuous real-world data collection from devices in use. Episodic site visits and paper questionnaires do not meet that cadence; the data has to come from where the device is used, which is the patient's home.
The platform collects device and patient-reported data at home and delivers one traceable dataset alongside the manufacturer's existing systems, with provenance, identity assurance, a signal-confidence score and an audit trail on every record.
The company runs the study at the service level the manufacturer chooses, from platform licence to a fully run study with subcontracted sites, and produces the regulatory deliverables at fixed prices.
Why now
Two regulatory timelines are moving clinical evidence into the home.
ICH E6(R3) Annex 2
Annex 2 of ICH E6(R3), covering decentralised elements and pragmatic trials, takes effect in the European Union on 15 January 2027. Sponsors and academic trial units running remote or hybrid elements will need to show how their data flows meet it.
ICH E6(R3) Annex 2 readiness assessmentEU MDR post-market clinical follow-up
EU MDR post-market clinical follow-up obligations push device manufacturers to collect real-world data from devices in use continuously, not episodically.
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