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Regulatory

About Rinicare

Registered Address Alderley Park | Congleton Road | Macclesfield | SK10 4TG.

Registered in England & Wales, company number 04443057.

Key contacts

Main Contact – [email protected]
Technical Support – [email protected]
Caldicott GuardianStuart Grant (contact)
Clinical Safety Officer – Stuart Grant (contact)
SIRO (Senior Information Risk Owner)Anthony Holmes (contact)
DPO (Data Protection Officer) and IG LeadJames Jackson (contact)

Response times

Our peak hours are between 9am-5pm UK time, Monday to Friday excluding public holidays. All requests submitted to the Helpdesk will receive a response based on an assigned priority; Rinicare aims to make the initial contact within one business day and aims to provide a resolution within 20 business days.

Rinicare will negotiate a schedule for resolution for critical/high priority requests, meeting regulatory requirements in each relevant territory where medical device product is deployed.

Privacy and Data Storage Policy

We take the security and privacy of your data seriously and intend to comply with our legal obligations under the Data Protection Act 2018 (the ‘2018 Act’) and the EU General Data Protection Regulation (‘GDPR’) in respect of data privacy and security.

Our Data Privacy Notice covers:

We also have a Data Security Policy (QS-POL-018), available upon request. SSL and secure by design/infrastructure is part of our deployment procedures.

Certifications and compliance

STABILITY™ AF: Atrial Fibrillation

Intended use

Stability AF is intended to calculate and display a patient-specific probability of developing atrial fibrillation in the early postoperative period. It is intended to be used by qualified medical professionals managing the care of patients who have undergone cardiac surgery.

Certification

Papers

STABILITY™ UO: Urine Output

Intended use: Stability UO is intended to calculate and display a patient-specific probability of the individual’s urine output reaching a pre-specified threshold. It is intended to be used by qualified medical professionals managing the care of patients who have undergone cardiac surgery and who have indwelling urinary catheters.

Certification

Papers

S.A.F.E.

Intended use: SAFE is intended to assist with patient positional monitoring in a bed area for the purpose of detecting and preventing falls. It is intended to gather thermal sensor data, generate positional iconography and display positional classification information and alarms on a computer, phone or tablet. It is intended to be used by an individual monitoring a patient in a bed.

Certification

SAFE in the news

PRIME-IoT

Intended use: PRIME-IoT is intended for the collection of data from Bluetooth sensors and the transmission of data to compatible devices for viewing and storage. The device is intended to be used by professionals in home and business environments.

Intended user group: The PrimeIoT system targets two types of user groups: (i) the end users, typically doctors or any other healthcare professional; (ii) the system administrators and maintainers, which are responsible for setting up the system so that the end user will be able to use it normally. The latter user category is mostly involved in the initial setup of the PrimeIoT hub system and first level of maintenance activities, typically client support and troubleshooting.

Additional