Evidence backed.
Sensore is built to the highest standards of safety, performance and data privacy.
Durable by Design
Sit down. Ten thousand times.
A pressure map has one job that matters above everything: keep reading true, day after day, year after year. So we gave the S1 to the National Physical Laboratory (the UK’s national independent measurement institute) and let their calibrated rig do the sitting, ten thousand times.
Behind the Testing.
Snapshots from the lab and the bench: the work behind the claims.
10,000 sit-cycle rig at NPL
Individual Pixel Calibration
Engineered Reliability
Regulatory status
Where S1 and M1 stand today.
The Sensore S1 and M1 are pre-UKCA Class I medical devices under the UK MDR 2002.
S1 is in the final stages of regulatory approvals with launch expected in early 2027. The M1 is in development, with launch expected in late 2027.
Quality & standards
The standards behind the system.
Sensore is developed under an ISO 13485-aligned quality management system with ISO 14971 risk management, and is being built and tested against:
| Standard | What it covers | Why it matters |
|---|---|---|
| UK GDPR | Personal data protected by design, in line with UK data-protection law | Sets the rules for how a person's pressure data is collected, stored, shared and deleted. |
| IEC 60601-1 & 1-2 | Electrical safety and electromagnetic compatibility | Covers electrical safety and how the system behaves alongside other electrical equipment. |
| IEC 60601-1-11 | Requirements for medical devices used in home healthcare | Written for use at home, where power, temperature and the people using the device differ from a clinic. |
| IEC 60529 | Ingress protection, IP22 rating | Rates how well the hardware keeps out fingers, objects and dripping water in everyday use. |
| IEC 62366-1 | Usability engineering for medical devices | Sets out how the usability of the mat and app is engineered and tested for the people expected to use them. |
| ISO 10993-1 | Biocompatibility of skin-contact materials | Sets out how materials that sit against the skin are assessed for irritation and sensitisation. |
| IEC 62304 | Software lifecycle for medical device software | Shapes how the software in the app and control unit is specified, built, tested and maintained. |
| IEC 81001-5-1 | Cybersecurity for health software and systems | Requires threats to the system and the data it holds to be identified, designed against and kept under review. |
Class I under UK MDR 2002; UKCA marking expected early 2027.
Data & privacy
Your data, handled with care.
Pressure data streams securely from the mat to the cloud and to your app. Personal data is processed under UK GDPR.
Research
The clinical case for continuous pressure mapping.
Spinal Cord, 2022: continuous pressure monitoring and ulcer development.
Sprigle & Sonenblum, 2011: the evidence for pressure redistribution.
Gefen, 2008: deep tissue injury mechanisms and time at load.
Stekelenburg et al., 2007: pressure, ischaemia and tissue damage.
Miao et al., 2025: recent evidence on continuous pressure monitoring.
Aylward-Wotton et al., 2025: continuous pressure monitoring in community care.