Handling Point-of-Care Devices in Clinical Trials
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With Device360™, you’re not just buying a service — you’re gaining a global compliance partner. We help you reduce risk, accelerate timelines, and protect the integrity of your trial data.
Point-of-Care (POC) devices—whether hardware, software, or a combination—are increasingly used in decentralized and hybrid clinical trials for diagnosis, monitoring, and treatment. When they influence trial endpoints or patient safety, they fall under medical device regulations worldwide, even if they are not the investigational product.
Why regulation applies:
Any device that collects data for regulatory submissions is regulated.
Roles (Manufacturer, Importer, Distributor, System Producer) come with specific obligations in each jurisdiction.
Non-compliance risks include audit failure, trial delays, and invalidated data.
Applicable frameworks: EU MDR 2017/745 (Articles 10, 13–16, 22), ISO 13485:2016, FDA 21 CFR 820/816, IVDR 2017/746, UK MDR 2002, Canada SOR/98-282, China NMPA, Japan PMDA, …
Your all-in-one POC Device Enablement Suite: Device360
Device360 is qointa’s end-to-end solution for regulatory-compliant selection, validation, integration, training, and oversight of POC devices in decentralized clinical trials. Built to align with ISO 13485, FDA 21 CFR, EU MDR, PMDA, NMPA, Health Canada, and UK MDR, Device360 streamlines compliance, reduces risk, and accelerates time-to-site.